TraceGuard AI

FSMA 204 readiness, without the panic

The FDA Food Traceability Rule (FSMA Section 204) is now enforced starting July 20, 2028. That is not a reason to ignore it. It is a two-year window to get ready calmly.

What the rule requires, in plain English

If you manufacture, process, pack, or hold foods on the FDA's Food Traceability List (FTL), you must keep specific records called Key Data Elements (KDEs) at specific supply chain steps called Critical Tracking Events (CTEs), and be able to produce them in a sortable electronic spreadsheet within 24 hours of an FDA request.

  • Receiving (a Critical Tracking Event)

    You take in an ingredient or product from a supplier.

    Key Data Elements include: Lot code, quantity and unit, product description, ship-from location, receive date, reference documents such as the BOL.

  • Transformation (a Critical Tracking Event)

    You turn ingredients into a new product.

    Key Data Elements include: Input lot codes, new lot code created, product description, quantity, location, and date.

  • Shipping (a Critical Tracking Event)

    You send product to a customer.

    Key Data Elements include: Lot code, quantity, ship-to location, ship date, and reference documents.

You also need a written traceability plan describing how you assign lot codes and keep these records.

The good news: you likely already keep most of this data

If you track suppliers, ingredients, lots, shipments, bills of lading, and customers, you already hold the raw material for FSMA 204 records. What most small and mid-sized companies are missing is not data. It is the rule's vocabulary: knowing which of your foods are on the FTL, which of your records map to which KDEs, and where the gaps are.

That is exactly how TraceGuard AI approaches it. Your Records Library already captures lots, compositions, inbound and outbound shipments, and BOLs. Our upcoming FSMA 204 Readiness Assessment maps those records to CTEs and KDEs, flags FTL foods, and gap-scores what is missing, using the same severity-graded gap engine that powers mock recalls today.

What you can do this quarter

  • Check the FDA Food Traceability List against your product catalog.
  • Move lot, shipment, and supplier records out of spreadsheets into one auditable library.
  • Run a timed mock recall. The 24-hour records expectation is much easier when trace retrieval is your team's practiced routine, not a fire drill.
  • Draft a simple traceability plan: how you assign lot codes and where records live.

Where TraceGuard AI fits

TraceGuard AI is the recall-readiness platform for small and mid-sized food companies: review your records, assess your readiness with a timed mock recall, and determine exactly what to fix. FSMA 204 readiness builds on that same spine.

TraceGuard AI provides readiness assessment tooling, not legal or regulatory advice, and no software can certify FSMA 204 compliance. Consult your regulatory advisor or PCQI for determinations specific to your operation.

Get your Recall Readiness Score or talk to the team about the FSMA 204 design-partner program.