FSMA 204 content hub

FSMA 204 is the FDA's Food Traceability Rule. Covered firms handling foods on the Food Traceability List keep event-specific traceability records and make requested records available to FDA within 24 hours, or a reasonable time FDA agrees to.

It applies to people who manufacture, process, pack or hold foods on the FDA Food Traceability List for US consumption, including some farms, processors, distributors and retailers. The rule also has full and partial exemptions; check the exact food and activity.

Critical Tracking Events are the rule's named record points: harvesting, pre-packing cooling, initial packing, first land-based receiving, shipping, receiving and transformation. Key Data Elements are the specific facts required for the event; the list differs by event.

ImpactRecall is designed to connect lot-level receiving, transformation and shipping records, validate missing data and support request-scoped retrieval. The available automation and integrations depend on the configured deployment and source systems.

A mock trace is a useful readiness test: select a covered lot, follow it upstream and downstream, measure retrieval time and log gaps. Confirm the exact mock-recall workflow available in your ImpactRecall deployment.

It depends on the number of products, sites and partners, the quality of existing lot data, and the systems being connected. Start with one covered product flow and validate records end to end before expanding.

A covered firm must make the requested records and information needed to understand them available within 24 hours, or a reasonable time FDA agrees to. In an outbreak, recall or other public-health threat, FDA may also request an electronic sortable spreadsheet unless an exemption applies.

FSMA 204 does not mandate one technology. Partners need to provide the applicable traceability information in an agreed, usable form. Confirm the supported exchange options and account requirements for your ImpactRecall deployment.

FDA identifies January 20, 2026 as the original compliance date and has proposed moving it to July 20, 2028. Congress directed FDA not to enforce before July 20, 2028, and FDA says it intends to comply. Check FDA's current compliance-date section before relying on a legal deadline.