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Indonesia Track and Trace Regulations: What They Mean for the Pharma Industry

Posted on by rfxadmin

Indonesia track and trace regulations are designed to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the supply chain. The goal is to protect consumers and increase patient safety, as well as boost Indonesia’s competitiveness in the pharma global pharma industry.

The National Agency of Drug and Food Control (BPOM) began rolling out regulations in 2018. In 2022, it established provisions and procedures for implementing 2D DataMatrix codes for drug and food products. The country’s digital platform is called the Track and Trace Anti-Counterfeit (TTAC) system.

Key regulations went into effect in 2023; the next big deadlines are set for 2025 and 2027. So let’s take a closer look at Indonesia track and trace regulations and what they mean for the pharma industry.

Indonesia’s Pharma Market in Context

At the time of writing, Indonesia’s population is approaching 279 million — the fourth largest in the world. It’s no surprise, then, that the sprawling archipelago is the largest pharmaceutical market in Southeast Asia.

According to Business Indonesia, sales of medicines in 2020 were valued at about $7.6 billion (110.6 trillion rupiah); this is expected to increase to more than $11 billion (176 trillion rupiah) by 2025. In terms of U.S. dollars, this equates to a compound annual growth rate of 10.7 percent.

Furthermore, the Indonesian government is making significant investments in the country’s healthcare system. The same Business Indonesia article reported that healthcare spending in 2022 accounted for 9.4 percent of the total government budget.

In this context, Indonesia is seeking to expand and open its pharmaceutical sector to foreign participation and investment. Pharma companies that already have an in-country presence or that want to enter the market must fully understand — and comply with — Indonesia track and trace regulations.

The Framework of Indonesia Track and Trace Regulations

Most of today’s global pharma compliance requirements have a few things in common:

      • Companies must register products with a country’s regulatory body.
      • Companies must send compliance information to a centralized system (e.g., a portal or website like Indonesia’s TTAC).
      • Products must be labeled in a manner that identifies them at the unit level (i.e., serialization) and/or a “higher” level, such as a pallet or case (i.e., aggregation).
      • Regulators prefer GS1 labeling standards [e.g., 2D DataMatrix codes, Global Trade Item Numbers (GTINs), and Serial Shipping Container Codes (SSCCs)]. Read our “Understanding GS1 Barcodes in the Global Supply Chain” article for a comprehensive overview of these standards.

Indonesia track and trace regulations follow this basic framework:

Registration

Imported and locally produced medicines must be registered with the BPOM before they can be distributed. Pharma companies must have a local business agent or partner to register products, and it’s advisable to obtain all permissions before exporting products to Indonesia.

Labeling

The BPOM requires all medicines sold in Indonesia to be labeled for identification, and upcoming regulations will further require products to be labeled for authentication. The BPOM uses GS1 standards.

Identification Barcodes

Starting on December 7, 2023, traditional medicines and over-the-counter drugs — as well as cosmetics, supplements, processed foods, and some raw materials — were required to be labeled with a QR code that identifies the product in the market and verifies that it’s legal. For products that do not have to be serialized, this is the only marking required.

Identification codes must contain a Marketing Authorization Number and an NIE, or Nomor Izin Edar, which can be translated as “distribution permit number,” both issued by the BPOM. Alphanumeric NIEs provide master product data, including where the product was manufactured, and allow verification through a database called Cek Produk BPOM (“Check BPOM Products,” roughly).

Authentication Barcodes

December 7, 2025, is the deadline for serializing and labeling narcotics and psychotropics (e.g., antipsychotics and antidepressants) with a 2D DataMatrix code. By December 7, 2027, all prescription drugs, including biological products, must be serialized and authenticated. Aggregation, following GS1 standards, is also required.

The authentication codes must contain the following information:

      • A GS1 Global Trade Item Number (GTIN)
      • A Marketing Authorization Number from the BPOM
      • A production code or batch number
      • An expiration date
      • A serial number

Companies can obtain codes from the BPOM or from an independent source.

Some products/packs are exempt from the authentication requirement. These include blister packs, strip packs, pre-filled syringes, stick packs, single packaging, and catch covers.

Other Indonesia Track and Trace Regulations: Distribution

The BPOM has other requirements coming into effect between 2024 and 2026:

      • December 7, 2024: Distribution centers with minimum stock keeping units (SKUs) of 1,500 serialized products must submit reports to the BPOM.
      • December 7, 2025: “Second-tier” distribution centers (min. 750 serialized products) must submit reports to BPOM. Note that this coincides with the deadline for serializing and labeling narcotics and psychotropics.
      • December 7, 2026: “Third-tier” distribution centers (min. 400 serialized products) must submit reports to BPOM. This applies to certain categories of pharmacies or clinics.

Electronic Leaflet Pilot (2023-2025)

A pilot for electronic leaflets (e-leaflets) began in July 2023 and is scheduled to conclude in July 2025. Wanting to transition from a paper-based system, the BPOM plans to develop a dedicated mobile app for scanning a single code (likely the mandated GS1 2D DataMatrix code) that will take users to information online. The pilot is being conducted in three phases:

      • Phase I for vaccines and injections (completed)
      • Phase II for prescription drugs, including vaccines and injections (completed)
      • Phase III for over-the-counter and prescription drugs, including vaccines and injections (in progress)

Final Thoughts About Indonesia Track and Trace Regulations

As we said above, Indonesia is seeking to expand and open its pharmaceutical sector to foreign participation and investment. Pharma companies that already have an in-country presence or that want to enter the market must fully understand — and comply with — Indonesia track and trace regulations.

This is where we can help. Our solutions for global pharma compliance will help ensure you’re prepared for Indonesia’s requirements for product identification, serialization, and aggregation.

It’s all part of our 20-year commitment to protecting patients, combatting counterfeit drugs, and securing supply chains. Our solutions report into all global government agencies, help ensure you meet your regulatory obligations, and protect products and people everywhere you do business. Contact us today to learn how it works!

 

 

FSMA Produce Safety Rule: Cultivating Compliance in Agriculture

Posted on by rfxadmin

The Food Safety and Modernization Act (FSMA) is going to have a major impact on the food industry. FSMA gives the Food and Drug Administration (FDA) enforcement capabilities to promote food safety, transparency, and quality, and the FSMA Produce Safety Rule is particularly important to the changes.

The FSMA Produce Safety Rule applies to commercial growers, harvesters, and packers of produce. The rule includes preventive controls designed to mitigate the spread of pathogens and foodborne illness through agricultural water, wild animals, and any raw agricultural commodity designed for human consumption. Here’s what you need to know.

Importance and Business Value of the FSMA Produce Safety Rule

In effect since January 26, 2016, the FSMA Produce Safety Rule (“Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”) is a major step forward for agricultural traceability, food safety, and public health. As the FDA explains, it “establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the Agency’s ongoing efforts to implement the FDA Food Safety Modernization Act.”

Familiarizing yourself with the FSMA Produce Safety Rule will help comply USDA and FDA regulations, avoid fines or other regulatory penalties, and promote business continuity. From a value-addition perspective, compliance means you’ll safeguard your products, appeal to consumer demands for transparency and accountability, and protect your brand reputation.

Key Components of the FSMA Produce Safety Rule

The FSMA Produce Safety Rule is built around Good Agricultural Practices. Those practices address the following areas:

Agricultural Water

Water, essential in agriculture, can be a major source of contamination. Both production and post-harvest water require careful management, which may include:

      • Regular testing and monitoring of surface and ground water for pathogens
      • Water treatment to meet safety standards
      • Maintenance and inspection of water sources

Strictly monitoring and protecting water is vital for ensuring compliance with the FSMA Produce Safety Rule.

Employee Health and Hygiene

Employee health and hygiene are paramount when dealing with produce for human consumption. When workers are sick or lacking training, they’re more likely to become (unintentional) sources of contamination.

Examples of health and hygiene requirements include instructing employees to notify their supervisors if they may have a health condition that may result in contamination of covered produce or food contact surfaces, using hygienic practices when handling such produce or surfaces (e.g., washing and drying hands, and taking measures to prevent visitors from contaminating produce and surfaces).

Domesticated and Wild Animals

Grazing animals (e.g., livestock), animals used for work applications, and wild animals (e.g., deer and feral swine), can compromise produce safety. The FSMA Produce Safety Rule requires farmers “to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated.”

These measures include visually examining the growing area and all covered produce to be harvested and, in some circumstances, conducting an additional assessment during the growing season and taking reasonable steps to assist during harvest if significant evidence of potential contamination by animals is found, such as placing flags outlining an affected area.

Biological Soil Amendments

Biological soil amendments of animal origin (BSAAO) are soil amendments that contain materials of animal origin. These materials may include raw manure or non-fecal byproducts such as table waste, animal carcasses, or any combination thereof.

Though biological soil additives can enhance the quality and nutrient profile of soil, they also carry some risks. Therefore, make sure that any additives are properly treated to reduce pathogens.

Production of Sprouts

Sprouts are particularly vulnerable to contamination by dangerous microbes due to the warm, moist, and nutrient-rich conditions needed to grow them. The FSMA Produce Safety Rule has requirements to help prevent the contamination of sprouts, such as:

      • Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting
      • Treating seeds or beans that will be used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation)
      • Testing irrigation water for certain pathogens and attaining negative results
      • Testing the growing, harvesting, packing, and holding environment for the Listeria species or Listeria monocytogenes
      • Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive

Equipment, Buildings, Tools, and Sanitation

The condition and cleanliness of your farm’s infrastructure — greenhouses, germination chambers, and toilet and hand-washing facilities — play a crucial role in compliance and safety. The FSMA Produce Safety Rule establishes standards related to equipment, tools, and buildings to prevent them from contaminating produce, including from inadequate sanitation.

Therefore, you should establish a routine for cleaning and sanitizing tools, equipment, and buildings. Regularly inspect and maintain equipment to prevent it from becoming a contamination source. Where possible, design facilities and equipment to be easily cleaned and to prevent harborage of pests and accumulation of dirt.

Compliance Guidelines for Farmers

The FDA provides resources explaining FSMA requirements, including the Produce Safety Rule. Let’s look at some practical tips for promoting and simplifying compliance.

One major hurdle is creating an actual compliance policy. If you run a farm, you need a comprehensive policy that addresses all facets of the Rule. This fact sheet from USDA is a helpful tool for designing and implementing your policy. If you operate a large farm, read the FDA’s “What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety Rule” here. Also check out the Sprout Safety Alliance at the Illinois Institute of Technology and the Produce Safety Alliance at Cornell University’s College of Agriculture and Life Sciences, for example.

Once you know which rules apply to your farm, develop a plan to address each relevant area. Remember, incremental improvements to enhance safety is a place to start; you don’t have to revamp your entire operation overnight.

Recordkeeping and Documentation

FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). If the Produce Safety Rule applies to your business, you should also familiarize yourself with The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule.”

FSMA 204 requires you to maintain (keep) and share accurate records of your products as they move through the supply chain. If you get audited, you’ll have to produce these records. Download our food traceability white paper to learn more about these requirements.

Water Quality and Agricultural Practices

The water quality provision (and most other provisions) of the FSMA Produce Safety Rule went into effect in 2018. Since then, the FDA has been ramping up enforcement actions. They have paid particularly close attention to water quality. Under the rule, you have to test the untreated groundwater for generic E. coli. If you use water that has been treated with a validated process or from a public source, testing is not required. Additionally, you are prohibited from using any untreated surface water for harvest or post-harvest purposes.

Soil Amendments

The FSMA Produce Safety Rule includes other provisions regarding soil usage — specifically, the introduction of animal byproducts into your soil. If using raw manure or any other animal byproducts to enhance soil productivity, you must take precautions to mitigate the risk of contamination. Be careful when sourcing manure and other animal-based soil enhancements, and always verify that the provider is compliant with FSMA provisions.

Final Thoughts: Being Proactive Simplifies FSMA Compliance

The FSMA Produce Safety Rule is being enforced now, and the deadline to comply with FSMA 204 traceability requirements is January 20, 2026. As we’ve said all along, the key to FSMA success is to be proactive. Specifically:

      • Study the law and know your obligations and your trading partners’ obligations.
      • Talk with your trading partners to ensure they’re compliant now and preparing for January 2026.
      • Assess your operations for compliance with the FSMA Produce Safety Rule and Food Traceability Final Rule.
      • Make sure you’re working with a knowledgeable and reliable solution provider — someone who can help you comply while keeping your supply chain moving at peak performance and leveraging the FSMA regulations to create business opportunities.

This is where we can help. We offer a full-stack solution for the food industry. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

Foreign Supplier Verification Program (FSVP): What It Means for FSMA

Posted on by rfxadmin

The Food and Drug Administration Food Safety and Modernization Act (FSMA) is going to change how the U.S. food supply chain works. And not just for U.S. companies. When the law takes effect in January 2026, foreign companies that import food to the United States must also comply. This is what the FSMA Foreign Supplier Verification Program (FSVP) is all about.

If you’re an importer, you’re subject to the FSVP under FSMA. If you’re a U.S.-based company, you want to make sure your non-U.S. trading partners are compliant.

Here is everything you need to know about the FSVP so that you can achieve and maintain FSMA compliance.

What Is an Foreign Supplier Verification Program? What Is the Significance?

Technically, FSVP stands for Food Supplier Verification Programs (plural). An FSVP is a program that promotes traceability, food safety, and transparency across the entire food supply chain. It mandates that importers perform certain activities to facilitate public health protection and verify that imported food meets the FSMA safety requirements.

Under a Foreign Supplier Verification Program, importers are required to verify that the food they import meets U.S. safety standards. They must develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal, therefore, is to ensure that every imported food has been produced in a way that delivers the same level of public health protection as the applicable FSMA requirements, and that food is not adulterated or misbranded with respect to allergen labeling.

Why is the Foreign Supplier Verification Program necessary? The answer is simple: The United States imports billions in food each year. According to the USDA, the U.S. imported $148 billion in agricultural products in 2020. U.S. food also includes a huge amount of imported animal products.

By extending FSMA requirements to importers and their suppliers, the Foreign Supplier Verification Programs promote increased safety and accountability. It also provides insights into each foreign supplier’s performance, enabling U.S. food businesses to make informed decisions about their trade relationships and promote good manufacturing practices.

Who Is Covered by the FSVP?

It defines an importer as “the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry).” If there isn’t a U.S. owner or consignee at time the product enters the USA, the FSVP defines the importer as “the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.”

The important takeaway is that there must be a U.S.-based FSVP importer who takes responsibility for meeting the FSVP requirements.

Key Components of the FSVP

The Foreign Supplier Verification Program is built on widely accepted food safety standards and preventive controls rules. Key FSVP requirements include the following:

      • Hazard analysis: Importers must analyze hazards associated with each food.
      • Supplier verification: The FSVP outlines appropriate supplier verification activities that importers must complete.
      • Corrective actions: Procedures must be in place to address identified issues.

Requirements for Importers

An FSVP importer may need to perform the following activities, unless they’re exempt or subject to modified requirements.

Verify Suppliers

Conduct appropriate supplier verification to assure that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include annual onsite audits by a qualified auditor, sampling and testing food, and reviewing the supplier’s food safety records.

Perform a Hazard Analysis

Hazard analyses must include identifying “known or reasonably foreseeable hazards” and determining if they require a control. The FDA notes several types of hazards, including the following:

      • Biological (e.g., parasites and disease-causing bacteria)
      • Chemical (e.g., radiological hazards, pesticide and drug residues, natural toxins, unapproved additives, food allergens, and nutrient deficiencies or toxicities in animal food)
      • Physical (e.g., objects in food products such as glass)

Evaluate Risks

You must evaluate risks that the food itself and the foreign supplier’s performance could pose. In doing so, you must consider the following:

      • Your hazard analysis for the food
      • Who will apply the hazard controls (e.g., the supplier or its ingredient supplier)
      • The supplier’s food safety practices and procedures
      • Applicable U.S. food safety regulations and information about the supplier’s compliance
      • The supplier’s food safety performance history, which should include testing and audit results and the supplier’s record of correcting identified problems.

Perform Periodic Reassessments

You have to reassess your foreign suppliers every three years — or sooner if the FSVP importer becomes aware of new information about hazards in the food or changes in the foreign supplier’s performance.

Identify the FSVP Importer

As an FSVP importer, you are required to provide the U.S. government with the following information about your organization:

      • Legal business name
      • Electronic mailing address
      • Unique facility identifier (UFI)

The FDA accepts the Data Universal Numbering System (DUNS) number as a UFI. FSVP importers temporarily unable to obtain a DUNS number have since May 2017 been permitted to transmit the value “UNK” (i.e., “unknown”) in the UFI field, allowing food to be processed through the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system, even if the importer has not yet provided a DUNS number.

Other Requirements

You must use a qualified person to develop an FSVP and to perform FSVP activities.

Furthermore, you must take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate). The corrective action will depend on the circumstances; for example, the best course of action may be to stop using the foreign supplier until the problem (e.g., noncompliance, adulteration, misbranding) has been adequately addressed.

Last, you’re required to maintain detailed FSVP records. A U.S. agent can request these records during an audit. Alternatively, they might review them during a randomized compliance assessment. Make sure you retain all digital records related to your FSVP compliance activities for at least two years.

Role of Technology in FSVP Compliance

Old-school compliance strategies can’t keep pace with the stringent recordkeeping and analytics mandates found in the Foreign Supplier Verification Program framework. Instead, you need a robust suite of technologies designed to accelerate and simplify compliance.

Adopting food supply chain software will empower your team to gather and manage key details about trading partners. With the right tools in place, you can transform food safety and regulatory compliance into an integrated part of your company culture.

Collaboration with Foreign Suppliers

FSVP compliance is a joint effort; you cannot achieve and maintain compliance without the support of your foreign suppliers. Reputable and successful foreign suppliers will embrace FSVP, as they understand that they cannot import their goods to the United States without complying.

Use this to your advantage. Reach out to your trading partners, relay what requirements apply to your organization and its operations, and develop a cohesive strategy to meet FSVP provisions. Building strong relationships with suppliers is key to a successful verification and hazard mitigation program.

FSVP Rollout and Influence

To date, compliance with the Foreign Supplier Verification Programs has been a challenge for many importers. According to a 2020 FDA report, in 2019 the Agency issued 340 citations to companies for failing to develop an FSVP — a 17 percent increase over 2018. In total, there were 354 non-compliance citations, including for failing to:

      • Follow or maintain the FSVP
      • Translate the FSVP into English when applicable
      • Sign and date the FSVP upon modification
      • Make adequate assurances of a supplier’s food safety

Over the last two years, the FDA has ramped up enforcement, which means that preparedness and diligence are more important than ever. As the Agency itself says, “Being prepared is key to avoiding a citation.”

Even with these challenges, the food industry should anticipate that FSVP will have a broader, sustained impact on global food supply chains. Along with FSMA, it encourages international suppliers to elevate their food safety standards, adopt best practices, and embrace food safety in a digital, traceable supply chain. This will lead to a more uniform global food safety system, enhancing consumer confidence in the safety of foods everywhere.

It’s likely that more and more countries will enact or continue rolling out similar food safety regulations on imported goods. When they do, it will accelerate the push toward safer, more sustainable food production practices.

Final Thoughts: Achieve Foreign Supplier Verification Program Compliance

As we’ve seen, the FSVP requires a lot of importers and their foreign suppliers, and many organizations have struggled with compliance.

The keys to success (and avoiding citations and fines) are preparedness and proactive implementation of FSVP practices and technologies that will yield a safer and more transparent food importation process.

If you don’t know where to start, contact us today to book a demo. Our traceability and transparency solutions for the food and beverage industries not only take the guesswork out of compliance — they transform all your supply chain data into true business value.

EPCIS DSCSA Exceptions Handling: What Is It and Why Is Everyone Talking About It?

Posted on by rfxadmin

Just a little over four months into the FDA’s DSCSA extended stabilization period and with the clock ticking down to the November 27, 2024, compliance deadline, EPCIS DSCSA exceptions handling is top-of-mind in the pharma industry.

But why? Let’s take a look at EPCIS DSCSA exceptions handling and how we can deal with it to ensure DSCSA compliance.

EPCIS DSCSA Exceptions Handling Keeps Your Products Flowing

The DSCSA requires the interoperable, electronic exchange of serialized product data. Specifically, trading partners must exchange Transaction Information (TI) and Transaction Statement (TS) data every time a regulated drug changes hands.

Exceptions are errors that may occur when partners exchange this data using EPCIS. If there’s an exception, the product cannot move forward in the supply chain, which means it won’t reach patients and consumers in a timely manner. Furthermore, if exceptions aren’t resolved quickly, a product could be considered suspect or illegitimate.

This is why EPCIS DSCSA exceptions handling is top-of-mind for the pharmaceutical industry.

Given the complex nature of securely exchanging serialized product data, it’s logical to expect exceptions, especially in the early days of enforcement. The Healthcare Distribution Alliance (HDA) has identified six categories of EPCIS DSCSA exceptions:

      1. Data Issues
      2. Damaged Products
      3. Product, No Data
      4. Data, No Product
      5. Packaging
      6. Product Hold

Exceptions have been on the HDA’s radar for years. At its Traceability Online Seminar in November 2021, for example, industry leaders discussed establishing standards for dealing with exceptions. They also discussed example scenarios, such as overages as a “Product, No Data” exception. In this scenario, a downstream trading partner might have 16 cases arrive at its facility but receive EPCIS data for only 15 of those cases. How does it notify the manufacturer? How does the manufacturer correct the TI so the case can be removed from quarantine and be on its way?

The message is clear: Trading partners must focus on building a system that quickly communicates and resolves data issues so products can keep moving.

Note: Also remember that the DSCSA requires all partners to be authorized trading partners (ATPs). This isn’t necessarily relevant to our discussion today, but it’s a critical part of compliance.

EPCIS DSCSA Exceptions Handling Solutions: Communication and Collaboration

The most important thing to remember about dealing with exceptions is that trading partners must communicate and collaborate. You are not working in a vacuum, and there is not a “lone wolf” solution for exceptions handling.

Herein lies the challenge. The communication infrastructure in the pharma supply chain — emails, online portals, phone calls, and so on — wasn’t designed with DSCSA compliance in mind, let alone dealing with exceptions handling in an interoperable, electronic data-exchange system.

So, in order for an EPCIS DSCSA exceptions handling solution to be effective, it must be built on a foundation of fast, targeted, and precise communication between/among the right people. In the overages example above, this would mean the trading partner that received the extra case would know exactly who to contact at the manufacturer, what information to share with that person, and how long it would take to fix the data error.

Are You Ready for EPCIS DSCSA Exceptions Handling?

The FDA’s extended stabilization period has given the pharmaceutical industry an additional year to prepare for the full serialization of the U.S. drug supply chain, including being able to deal with EPCIS DSCSA exceptions handling.

This is good news for everyone. But you have to use this time to ask yourself the tough questions:

      • Do you have systems up and running?
      • Are you testing your systems?
      • Are you communicating and collaborating with all of your trading partners?
      • Are you complying with the DSCSA requirements that are enforceable right now?
      • Are you working with a solution provider that fully understands your role in the supply chain, your product(s), your business, and your DSCSA compliance needs?
      • Are you going to be ready for November 27, 2024?

We are here to help. We have led on the DSCSA since rollout began in 2014. Today, we’re working with the industry to develop a collaborative approach to exceptions handling using GS1-based error correction.

Don’t let bad data disrupt your business. Contact us today to learn more. We’ll ensure you receive compliant data from your trading partners, quickly resolve data quality issues, and keep your products moving.

FSMA Warehouse Requirements: A Comprehensive Guide for Compliance

Posted on by rfxadmin

Passed in 2011, the Food Safety and Modernization Act (FSMA) is transforming the U.S. food supply chain. The law applies to most members of the food supply chain, including harvesters, coolers, packers, processors, distributors, and retail food establishments. The deadline to comply with the regulations, including the Final Rule on Requirements for Additional Traceability Records for Certain Foods, is January 20, 2026.

As the deadline approaches, it’s vital to ensure you’re making preparations to comply. Though this definitely includes rules regarding harvesting and transportation it’s important to remember that FSMA also addresses food storage and warehousing. With that in mind, let’s take a deep dive into FSMA warehouse requirements and what they mean for your business.

Understanding FSMA Warehouse Requirements

FSMA includes a set of rules that govern food production and distribution. FSMA 204, the Food Traceability Final Rule, established additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).

There are seven other rules, some that could affect operations and compliance at your warehouses and other facilities:

      • Preventive Controls for Human Food: Must meet Current Good Manufacturing Practice mandates, perform hazard analyses, and implement preventive controls.
      • Produce Safety Rule: Must establish science-based standards for packing, production, and storage of fruits and vegetables
      • Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to demonstrate that they are meeting U.S. food safety standards
      • Sanitary Transportation Rule: Establishes regulations for sanitary transportation of food items
      • Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
      • Protection Against Intentional Adulteration: Aims to prevent foodborne illness by guarding against intentional adulteration
      • Voluntary Qualified Importer Program (VQIP): Optional fee-based program for foreign food facilities that want to import foods into the U.S.

We know it can be challenging to understand the FSMA rules. While focusing on the totality of the regulations — how they’ll affect your operations, your trading partners, the industry in general, and even consumers — always pay attention to the rules that pertain to your specific, day-to-day role in the supply chain.

For instance, if you operate food warehouses, be sure you understand the FSMA storage regulations just as well as you understand the FSMA 204 traceability requirements.

FSMA Warehouse and Storage Regulations

The primary goal of the FSMA regulations is to prevent foodborne illnesses and protect public health. Though this is the main driver for compliance, keep in mind that non-compliance can slow or stop your operations, damage to your brand reputation, and irk your customers and consumers.

With this in mind, here are the basics of FSMA warehouse requirements:

      • Pest Control: Food safety plans must protect food items from indoor and outdoor pests
      • Sanitation: Consumers must be protected from allergen cross-contact and pathogens
      • Temperature Controls: Especially important for animal foods like meat, eggs, and milk

Additionally, you’ll need to meet the FSMA 204 traceability requirements. Read more about those in our blog here.

Implications for Distributors

If you’re a distributor, FSMA warehouse and storage requirements directly affect your operations. The law requires you to keep and maintain records that show you and your partners are compliant and adhering to food safety requirements. This means you should be coordinating with your partners right now to make sure they’re preparing to share information and comply.

You’ll also need to closely monitor warehouse operations. Pay close attention to refrigeration guidelines, and take corrective actions immediately if you detect a deficiency. Also make sure you have the right sanitation controls in place, as this will help prevent cross-contamination.

Key Practices for Compliance

So what can you do to comply with FSMA? Beyond contacting us to discuss the requirements and the concrete steps you can take now, here’s a short list of things to keep top of mind:

Create a Food Safety Culture through Training

Your team is the first line of defense against outbreaks and compliance slip-ups, so make sure they have a foundational knowledge of the law. A well-trained team can help you be prepared for FSMA warehouse requirements and keep your facilities safe, compliant, and efficient. Training should include FSMA basics — traceability, modernization, food safety, etc. — as well as information about food processing best practices and your organizational commitment to safety and compliance.

Audit Your Processes

One key to compliance is to be audit-ready. The USDA or FDA may never come knocking, but you should act like it’s an inevitability. Conduct your own audits to identify compliance gaps in your storage and distribution processes. Internal audits will also reveal pain points and other inefficiencies that affect your operations.

Implement a Robust Recordkeeping System

FSMA stipulates that supply chain actors must maintain and share product information with their partners. The law also says that companies must share records with the FDA within 24 hours of a request (or within a mutually agreed-upon timeframe). If should you be audited, expect repercussions if you don’t have the required traceability information on hand.

Have a Plan for Safety — and More

Create a food safety plan and share it with your team. Anyone involved in maintaining food safety and preventing foodborne illness should know your plan inside and out.

You should also create a recall strategy. This should include how to share information with the FDA and other authorities and your trading partners. It should also include how to communicate with consumers about affected products and how to dispose of them safely.

Final Thoughts: Be Proactive with FSMA Warehouse Requirements

The best and quickest path to complying with FSMA warehouse requirements is to work with a reliable, experienced technology provider like us. Our supply chain solutions for the food and beverage industry will ensure you’re ready for January 2026 and the FSMA regulations for traceability, storage, and recordkeeping.

Connect with us today and one of our FSMA compliance and supply chain traceability experts can show you how it works. In about 15 minutes, you’ll have a better understanding of the law, how prepared you are, and how to get to full compliance by January 2026.

Antares Vision Group and rfxcel Welcome Kevin Huey as Senior Director of Professional Services

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Reno, Nevada, September 27, 2023. rfxcel, part of Antares Vison Group and a global leader in innovative supply chain traceability solutions, is pleased to announce that Kevin Huey has joined our team as Senior Director of Professional Services. With a background in supply chain management, project leadership, and a strong focus on nurturing talent within organizations, he brings wealth of customer-centric and operational experience to the team.

Kevin’s leadership style emphasizes people and processes. With a history of fostering the growth and professional advancement of technical teams, he is committed to motivating exceptional performance and creating an environment where people can thrive.

Kevin has held key roles at companies such as Ethicon Endo-Surgery, where he spearheaded critical initiatives in manufacturing engineering, operations program management, and supply chain readiness. At Biosense Webster, he established a Product Focus Team (PFT) structure to enhance lifecycle activities and collaborated extensively with different departments to identify and mitigate product and service risks. He also played a crucial role in shaping the supply chain during a company integration, ensuring seamless operations.

Most recently for Auris, he led a team of 16 engineers focused on process development and played a pivotal role in the manufacturing of first-in-human products. He also expanded their team through strategic recruitment efforts, ensuring a robust talent pool for ongoing projects.

“We are excited to welcome Kevin to the rfxcel family,” said rfxcel Chief Operations Officer Vikash Pushpraj. “His extensive experience and commitment to our core values of innovation, collaboration, and employee development align perfectly with our vision for the future.”

Kevin has a Master of Business Administration from Xavier University and a Bachelor of Science in Mechanical Engineering from Purdue University. This combination of technical expertise and business acumen helps him drive excellence in every facet of his work. He joins rfxcel poised to lead us into a new era of excellence in professional services, where innovation, people, and processes will drive our success.

Kevin Huey photo
AV Group and rfxcel welcome Kevin Huey to our team as Senior Director of Professional Services.

Seed Group Forges Pathway with rfxcel to Enhance Safety and Integrity of Supply Chains

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rfxcel and Seed Group logos on blue background

Reno, Nevada, and Dubai, United Arab Emirates, September 26, 2023. Seed Group, a company of the Private Office of Sheikh Saeed bin Ahmed Al Maktoum, has announced a strategic partnership with rfxcel, a renowned leader in the field of traceability, compliance reporting, product authentication, and consumer engagement solutions. This collaboration marks a significant milestone in enhancing business security and success within the UAE market and beyond and empowering the integrity of supply chains and brand owners in multiple industries such life sciences, food, beverage, cosmetics, oil, and gas.

The partnership between Seed Group and rfxcel, which is part of Italian multinational Antares Vision Group, is poised to reshape the landscape of business expansion and innovation in the UAE and the broader region. Seed Group, renowned for its expertise in fostering strategic collaborations, will play a pivotal role in guiding rfxcel’s expansion into the UAE market.

By leveraging its comprehensive network, Seed Group will facilitate access to key decision-makers across both the government and private sectors. This collaboration will undoubtedly pave the way for the seamless integration of rfxcel’s leading-edge technologies and digital innovations into the region.

Hisham Al Gurg, CEO of Seed Group and the Private Office of Sheikh Saeed bin Ahmed Al Maktoum, expressed his enthusiasm about the partnership, stating, “We are truly excited to join forces with rfxcel, a global leader that shares our commitment to pushing the boundaries of innovation. Through this strategic collaboration, we aim to deliver unparalleled value to businesses operating in the UAE. This partnership is a testament to our unwavering dedication to driving technological advancement and progress within the region.”

rfxcel CEO Glenn Abood also emphasized the partnership. “We see our strategic partnership with Seed Group as an opportunity to grow together in the UAE and beyond. We believe it is more than just building a business presence: We want to become Seed Group’s trusted partner as we help companies on their traceability journeys. We want to work together, leverage our respective strengths, and establish ourselves as leaders for innovation and business value.”

Founded in 2003, rfxcel emerged as an industry trailblazer by prioritizing the safety and integrity of the pharmaceutical supply chain. Over the last two decades, it has expanded its solutions into diverse industries, including food, beverage, cosmetics, oil, and gas. Its groundbreaking track and trace software has revolutionized the way supply chain stakeholders manage their operations. Guided by a commitment to innovation and excellence, rfxcel strives to remain at the forefront of traceability technology, working one-on-one with clients to optimize their business operations to drive value for the future.

As the company embarks on this new chapter of growth and expansion, both Seed Group and rfxcel are poised to make lasting contributions to the advancement of supply chain transparency, compliance reporting, and product engagement. The combined expertise of these two industry leaders promises to foster innovation, drive economic growth, and strengthen the foundations of businesses across the UAE.

Seed Group is a notable force in the technology, healthcare, hospitality, and telecommunications landscapes in the Middle East. Over the past 20 years, it has formed successful strategic alliances with leading global companies representing diverse regions to accelerate sustainable market entry and presence within the Gulf Cooperation Council countries.

For more information, contact rfxcel Senior Communications and Content Manager Garrison Spik at garrison@rfxcel.com.

About rfxcel

rfxcel, part of Antares Vision Group, is a leading provider of cloud-based supply chain transparency solutions. For 20 years, its mission has been to deliver value through scalable and interoperable software that ensures supply chain traceability, visibility, integrity, and regulatory compliance.

The company’s award-winning Traceability System offers solutions that create a digital supply chain with end-to-end visibility. Unit-level product data creates business value through innovations for product authentication, business intelligence, brand protection, and consumer engagement.

The rfxcel Traceability Hub provides a central repository from which governments and commercial organizations can gain visibility and control over every product in their supply chains. It can be configured to track any event, such as shipments, receipts, and customs clearance, helping to ensure that only legitimate products enter the supply chain, empowering citizens or governments to verify product authenticity, and providing full visibility to the inventory levels and locations of all tracked products. For more information, visit www.rfxcel.com.

About Seed Group

For over 20 years, Seed Group has formed strategic alliances with leading global companies representing diverse regions and industries. These companies have propelled their business interests and goals in the Middle East and North Africa region through the support and strong base of regional connections of the Seed Group. The Group’s goal is to create mutually beneficial partnerships with multinational organizations and to accelerate their sustainable market entry and presence within the MENA region. Seed Group has been a key point in the success of all its partners in the region, helping them reach their target customers and accelerate their businesses. The Private Office was established by Sheikh Saeed bin Ahmed Al Maktoum to directly invest in or assist potential business opportunities in the region, which meet The Private Office’s criteria. For more information, visit www.seedgroup.com.

Emidio Zorzella, Antares Vision Group’s Chairman, to Join the Healthcare Panel for the Sub-Saharan Africa Business & Investment Summit at the United Nations

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Emidio Zorzella_ Chairman and CEO of Antares Vision Group

New York, 25 September 2023. Emidio Zorzella, Chairman and CEO of Antares Vision Group, will be presenting the work of Antares Vision Group, and investments the Company has made in fighting counterfeit and dangerous drugs in Africa. Emidio is attending the 78th Session of the UN General Assembly and speaking on health and technology at the Sub-Saharan Africa Business Investment Summit.

“Every year, counterfeit and dangerous drugs lead to hundreds of thousands of deaths in Africa,” Zorzella said. “Earlier this year, 60 children in The Gambia alone were poisoned by contaminated cough syrup. These needless losses are hurting families across the African continent, but this crisis is preventable and has reached a point where it can no longer be ignored.

“Antares Vision Group, with its rfxcel pharmaceutical track and trace technology, is proud to be working with the President of Guinea-Bissau, The Honorable Umaro Sissoco Embaló, as he takes the lead in Africa to stop counterfeit drugs with our traceability systems. We are proud to invest in Africa to deliver solutions to save the lives of so many people and we look forward to doing so across the continent.”

His Excellency Ambassador Serge Mombouli of the Republic of Congo, who also serves as the Dean of the African Diplomatic Corps in Washington, DC, offered his support for the goal of eliminating counterfeit drugs in Africa. “This is a priority for President Denis Sassou Nguesso of the Republic of the Congo,” he said, “and it is my pleasure to invite you to my country to meet him and his health officials to discuss adoption of the rfxcel system to provide drug safety and security for our people.”

Governments around the world are beginning to take control of their supply chains, as they realize how dependent we all are. Criminals, opportunists, and even terrorist groups have begun capitalizing on the weaknesses of the global supply chain, and Antares Vision Group, through its Government Services team, is helping elected officials and Government organizations to strengthen protections for the health and safety of the public. Governments and Antares Vision Group have found success by partnering with various stakeholders in the supply chain to increase patient safety, eliminate the funding sources of criminal organizations, and provide a return on investment to all stakeholders.

 

About Antares Vision Group

Antares Vision Group is driving digitalization of products and supply chains by leading traceability, inspection, and integrated data management. AV Group helps companies and institutions to achieve safety, quality, efficiency, and sustainability, enabling Trustparency®.

DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and guarantees product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management, applying artificial intelligence and potentially blockchain.

With a strong focus on innovation, the company collaborates with universities and innovation centers; it is part of the Italian National Research Centre for the development of RNA drugs and has developed a traceability platform for agri-food products in collaboration with MISE (Italian Ministry of Economic Development) to ensure the authenticity and sustainability of Made in Italy products.

AV Group operates in the Life Science (pharmaceuticals, medical devices, and hospitals), Beverage, Food, Cosmetics, Chemicals, and Packaging industries and potentially many others.

AV Group has been listed in STAR segment of Euronext since 14 May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022.

In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,300 people, and has a consolidated network of over 40 international partners.

 

Antares Vision S.p.A.

Via del Ferro, 16 – 25039 Travagliato (BS) – Italy

T: +39 030 7283500

info@antaresvision.com – www.antaresvisiongroup.com

 

 

From Traceability Regulations Compliance to a Customized Service

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Collaboration between Ferring Pharmaceuticals and Antares Vision Group continues with a new testing and validation software and a better supply of spare parts.

Travagliato (Brescia), September 13, 2023. The collaboration, born in 2015, between Ferring Pharmaceuticals, a leader in reproductive medicine, maternal health, and specialist areas within gastroenterology and urology, and Antares Vision Group, a technological partner in digitalization of products and supply chains for companies and institutions, and a leader in traceability and inspection for quality control, continues. After an initial approach following the entry into force of the serialization regulations, Ferring Group currently uses Antares Vision Group solutions on 23 lines in plants in Switzerland, the United States, China, the Czech Republic, Israel, Scotland and Indonesia.

Thanks to the collaboration with Antares Vision Group, Ferring Group has significantly reduced procurement times for spare parts with integrated supply chain processes that always ensure the availability of the minimum quantity in stock, increasing the efficiency of maintenance operations. For spare parts, it is a reduction of over 90% in procurement times.

“This is one of the main benefits originating from the collaboration with Antares Vision Group started in 2015,” states Fernando Monteiro, Global OT Applications Senior Manager at Ferring Pharmaceuticals Group. “We went through challenging times in a growing serialization world. Regulations have been evolving over the years, impacting our production planning, sometimes making it more complex.”

Ferring Pharmaceuticals and Antares Vision Group have jointly developed customized solutions to improve maintenance operations. In particular, since many Ferring sites use the same components — which is convenient considering that having different spare parts at each site would be extremely costly — and a shortage of stocks would jeopardize business continuity, Antares Vision Group and Ferring have put in place a list of spare parts capable of covering the needs of the various plants involved. These components are in stock at the Antares Vision Group headquarters in Italy, available to be shipped worldwide at any time.

Due to the robust international agreement and exceptional collaboration between the two firms, Ferring Pharmaceuticals has seamlessly met specific requests, consistently ensuring adherence to the regulatory standards of every country they serve.

Furthermore, Ferring Pharmaceuticals has increased the level of efficiency of the production process during ordinary maintenance operations, not only by increasing the availability of spare parts, but also by adopting new solution for testing and qualifications to maintain operational continuity at the highest levels also in case of new releases and software updates.

To facilitate testing and qualification, a solution was developed that combines both hardware and software and replicates the functionality of Ferring’s production lines. This system can simulate operations in non-production settings such as offices and labs, making validation more accessible. Operating offline and without real packaging material, it enables comprehensive testing without disrupting actual production timelines.

“Our collaboration with Ferring Pharmaceuticals has evolved since the beginning following the needs and requirements of the customer,” concludes Mattia Assanelli, Service Director of Antares Vision Group. “By paying attention to regulatory developments and deepening the knowledge of the processes of the different Ferring sites, we have been able to improve production and maintenance efficiency, with a drastic reduction in spare parts procurement times and with a system that tests software updates, excluding the risk of line downtime.”

 

About Antares Vision Group
Antares Vision Group is driving digitalization of products and supply chains by leading traceability, inspection, and integrated data management. AV Group helps companies and institutions to achieve safety, quality, efficiency, and sustainability, enabling Trustparency®.

DIAMIND, AV Group’s integrated ecosystem of solutions, simplifies the technology environment and supports businesses growth by enabling a data-driven and tailored journey to digital innovation. Connecting physical products with digital identities, DIAMIND runs at the line, factory, warehouse, enterprise, and supply chain levels, and guarantees product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer and back) through integrated data management, applying artificial intelligence and potentially blockchain.

AV Group operates in the Life Science (pharmaceuticals, medical devices, and hospitals), Beverage, Food, Cosmetics, Chemicals, and Packaging industries and potentially many others.

AV Group has been listed in STAR segment of Euronext since 14 May 2021 and has been included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential, since July 2022.

In 2022, Antares Vision Group recorded a turnover of €223 million. The Group operates in 60 countries, employs more than 1,100 people, and has a consolidated network of over 40 international partners. www.antaresvisiongroup.com

About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries.

Contacts for more information:

Raffaella Mora | PR Specialist Antares Vision Group
raffaella.mora@partner.antaresvision.com
+39 349 0709470

Press Office
Soluzione Group S.R.L. – Via F. Lana, 1 – 25020 Flero (BS) – Italy
T: +39 030 3539159
Giusy Martin | Cell. +39 3881681168
martin@soluzionegroup.com

Antares Vision S.p.A.
Via del Ferro, 16 – 25039 Travagliato (BS) – Italy
T: +39 030 7283500
info@antaresvision.com – www.antaresvisiongroup.com

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© 2024 ANTARES VISION S.p.A. - Via Del Ferro, 16 - 25039 Travagliato - Brescia - ITALY Tel.: +39-030-7283500 / Fax.: +39-030-5109958 / info@antaresvision.com - C/F PIVA: 02890871201 Registro Imprese di Brescia C.C.I.A.A. di Brescia (REA) n. 523277