Traceability

The FDA Traceability Rule (FSMA 204) compliance date is being extended to July 20, 2028.
TRACEABILITY

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You now have until 2028 to comply with the FSMA 204 Traceability Rule. But with all that needs done, that’s closer than you may think!

TAG's Traceability Toolkit

If you’re interested in getting the full Toolkit or support from TAG on traceability, please click here. 

Traceability toolkit
DOWNLOAD CHAPTER 1

The Rule requires that you:

  • Determine if you are subject to the rule
  • Develop systems compliant with the rule
  • Identify appropriate data management tools
  • Identify the CTEs and required KDEs for your records
  • Analyze your processes for compliance
  • Provide a written report detailing applicable CTEs and KDEs and next steps for implementation

This Means: you must maintain additional records for foods on the Food Traceability List (FTL), including CTEs and KDEs:

  • CTEs (Critical Tracking Events). A food supply chain event involving the growing, receiving, transforming, creating, or shipping.
  • KDEs (Key Data Elements). Information associated with a CTE for which a record would have to be established and maintained. 

It’s Complex, but TAG can help!

FSMA FTL FOODS

Food Traceability List (FTL)

Where are you on your Food Traceability Journey?

Whether you’re nearly in compliance with the FSMA 204 Traceability Rule … just beginning your journey … or figuring out where to start — TAG can help!

TAG is offering an initial assessment of how the Traceability Rule applies to your facility or operation, with a written summary of the applicable CTEs and KDEs for only $500. To get started, submit the form at right and we’ll be in touch to schedule a call!

TAG can also be engaged for further consultation to assist with your approach to complete supply chain compliance and risk management. 

To  learn more about the current status of the FSMA 204 Traceability Rule, watch Traceability: Using the Compliance Grace Period to your Benefit.

The TAG Team of experts has decades of experience in U.S. and global regulatory agency and private industry executive positions – providing our clients with a unique multi-functional perspective and expertise. Contact us today!
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