TraceR2CFramework library / FSMA 204
Food & Beverage · regulatory framework
FSMA Rule 204 — Food Traceability Final Rule.
FDA’s traceability rule: keep and produce lot-level records for high-risk foods within 24 hours.
What it is
FSMA Rule 204 is the FDA’s Food Traceability Final Rule under the Food Safety Modernization Act. If you manufacture, process, pack or hold foods on the Food Traceability List (FTL), you must capture Key Data Elements (KDEs) at Critical Tracking Events (CTEs) — receiving, transformation, shipping — and be able to hand the FDA a sortable electronic record within 24 hours of a request. FDA has announced its intention to extend enforcement to July 2028, but the record-keeping burden lands on your supplier data today.
Who it applies to
Food & beverage manufacturers, co-packers, processors, distributors and importers handling FTL foods (soft cheeses, leafy greens, fresh-cut produce, seafood, ready-to-eat deli salads and more).
The evidence auditors expect
- Traceability plan describing how KDEs are captured and linked
- Lot codes assigned and carried through every transformation
- KDE records for each CTE: receiving, transformation, shipping
- Supplier lot-level documentation connected to your finished products
- Ability to export sortable electronic records within 24 hours
How ComplianceFlow keeps you ready
- Supplier evidence requests collect lot-level documents automatically, with reminders until they arrive
- Every document is linked to the supplier, facility and product it covers — the KDE chain auditors ask for
- One-click audit export assembles the records the FDA expects, in hours instead of weeks
Related frameworks
See FSMA 204 evidence assemble itself.
ComplianceFlow keeps a living copy of FSMA 204 mapped to your suppliers, products and evidence — so what you must prove is always current, and always exportable.
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