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FSMA Compliance

FSMA Section 204 Compliance

The FDA Food Safety Modernization Act Section 204(d) includes requirements that will help the FDA rapidly and effectively mitigate food-borne illness outbreaks and address credible threats of serious adverse health consequences or death.

How To Comply With FSMA Rule 204

Here are a few steps you can take now to prepare for FSMA Rule 204.





Identify products on the Food Traceability List you deal with.

Review what supply chain role you play with each of those products.

Learn the CTEs and KDEs you will be required to track based on your role.

Identify items for which entity has to generate Traceability Lot Code and items for which Traceability Lot Codes should be carried forward.





Address any internal process changes to ensure that you are properly aligned with the FDA defined receiving, transformation, creation and shipping CTEs (or growing in the case of farmer).

Drive an internal data readiness progress to ensure these KDE’s are captured and stored in the proper way and are easily accessible.

Talk to your supply chain partners about what they are doing to comply with FSMA Rule 204.

Start vetting different traceability solutions - Traceability projects take time and you should start ASAP.

How TagOne Can Help

With over 17 years of experience in the tech traceability space and having gone through the full cycle of the FDA traceability regulation in the pharmaceutical industry (the DSCSA Law), the TagOne team is uniquely positioned to help you navigate the tricky FSMA 204 waters. 

Our cloud native, traceability management system has been custom built for the Food & Natural Products Industry, tracking the industry’s unique processes (CTEs) and key data elements (KDEs) making end-to-end traceability a reality. One of TagOne’s main focus areas is ease of use so that companies can easily capture, store and share relevant data supporting their FTL products in the supply chain.

Keep in mind that although the FDA does permit paper records, technology in general and data digitization more specifically will be key for your company to address the FSMA Rule 204.

TagOne FSMA 204 SaaS Packages

Basic Compliance Pack

Our Basic Compliance pack is your low-cost option to successfully address the FSMA 204 ruling as it stands today. Key features include:

  • Self-setup of your company account on the TagOne traceability cloud

  • Digitization and store your specific CTEs and KDEs in the TagOne cloud via pre-built excel sheets or via the TagOne mobile app

  •  One-click FDA reporting in a matter of seconds

Compliance + Pack

Our Compliance + pack will give you all the functionality of your basic pack PLUS you'll get the following features:

  • Inventory Management

  • Master Data Management

  • Document Management

  • Ability to add supporting info beyond the KDEs to each transaction (Documents/Pictures/Data)

  • Traceability reports (one up/one down)

  • Recalls and Returns

  • Audit Logs

TagOne FSMA 204 Advisory + Roadmap Services

The TagOne team fully understands that comprehensive traceability is a journey and we will support you every step of the way.

  • Our traceability process consultants will work with you to map your existing processes to the Critical Tracking Events (CTEs) outlined in the proposed rule and identify all their supporting KDEs.

  • We will work with your team to identify any process gaps and work to come up with pragmatic solutions to address them.

  • We will conduct onboarding sessions for your TagOne users to ensure they fully understand the workings of the system and are easily able to capture the relevant KDEs against the mapped CTEs.

  • We will ensure that this information is securely stored on our AWS cloud so you can access it on an “as needed” basis.

Key Dates to Remember

  • Nov 7th, 2022 - Final Ruling expected. Under consent decree, FDA is expected to submit a final rule to the Office of the Federal Register by November 7, 2022

  • Jan 7th, 2023 - Final rule becomes law at the completion of 60 days of being published in the Federal Register

  • Jan 7th, 2025 - Companies across the supply chain dealing with items on the Food Traceability List need to comply with the law

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Key Points from the Final Law

  • Only products on the Food Traceability List (FTL) are in scope.

  • Companies will need to maintain records as original paper records, electronic records, or true copies (must be legible and stored to prevent deterioration or loss).

  • Once requested, companies will need to provide traceability records to the FDA in no later than 24 hours.

  • These records will need to be in an electronic sortable spreadsheet format containing relevant traceability information.

  • Traceability Lot Code -  a descriptor, often alphanumeric, which is used to identify a traceability lot.

  • Lot Code Transformation - Lot Code has to be created by specific role based on product (i.e. lot code for a crop would need to come from the Farmer, lot code for processing two products would need to come from the processor).

The TagOne Value

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Central Regulatory Repository

TagOne is your Single source of truth for all FDA-related traceability data and documents.

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Traceability Data Digitization

TagOne will enable you to Capture, Store, and Share relevant traceability data on an “as-needed” basis.

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Traceability Reports in Seconds

On a button-click, fetch the TagOne Traceability Map view or Table view report based on Item name/Lot#. This is all you will need in the case of an FDA inquiry.

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Traceability Consulting

TagOne is not only your tech traceability platform of choice but our traceability experts will help you navigate this traceability journey every step of the way.

Connect With Us

FSMA Connect
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