CALIFORNIA

FSMA 204

Be ready to retrieve, link, and share food traceability records with ease and speed.

What is FSMA 204?

FSMA 204 refers to the US Food and Drug Administration’s enhanced food traceability recordkeeping requirements, implemented under 21 CFR Part 1, Subpart S. The rule is designed to improve the FDA’s ability to rapidly trace certain foods through the supply chain by requiring detailed, linked records of critical tracking events and associated data.

Who it applies to and when

FSMA 204 applies to entities that manufacture, process, pack, or hold foods listed on the FDA’s Food Traceability List. Covered entities must maintain traceability records for defined events across the supply chain and be able to provide those records to the FDA within 24 hours upon request. The compliance date is July 20, 2028, following a 30 month extension issued by the FDA.

How Orijin Plus supports FSMA 204 readiness

Orijin Plus supports brands preparing for these requirements through a traceability platform designed to capture, link, and retrieve food traceability records across the full product lifecycle.

Event-based traceability aligned to FDA expectations

Orijin Plus enables traceability data to be captured and connected across Critical Tracking Events, including harvesting, receiving, transformation, and shipping. Records are linked through lots and transformations, maintaining continuity as products are combined, split, or processed across facilities.

24-hour record retrieval without manual reconciliation

Traceability data is stored in a structured, queryable format, allowing brands to retrieve and assemble required records quickly when requested. This reduces reliance on spreadsheets, emails, and fragmented systems when responding to FDA or partner requests.

Interoperable data sharing using GS1 identifiers

Orijin Plus operates a GS1-aligned resolver that associates traceability data with standard product and location identifiers. This enables traceability information to be shared efficiently with upstream and downstream trading partners, simplifying data exchange across the supply chain as FSMA expectations around interoperability continue to mature.

Future-ready traceability as requirements expand

As FDA guidance, enforcement practices, and industry data networks evolve, Orijin Plus allows brands to extend how traceability data is used. This includes supporting interoperable data sharing, integrating additional data sources, or participating in broader GS1-based traceability ecosystems without rebuilding core systems.