FSMA 204 records for every lot on the Food Traceability List.
Keep the traceability lot code and the key data elements of every critical tracking event with each lot, and see what is missing before anyone asks.
The challenge
The FDA's Food Traceability Rule (21 CFR Part 1, Subpart S) asks for records, event by event.
Foods on the list
It applies to foods on the FDA's Food Traceability List, and to the companies that grow, pack, process, ship and receive them.
Critical tracking events
Harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation each have their key data elements.
Traceability lot codes
A code assigned at initial packing or transformation follows the food, with where it was assigned.
How A-REX handles it
The records you already keep, with the code and the key data elements on each event.
Record the traceability lot code
On each lot, with the place where it was assigned.
Keep the key data elements of each event
Receipts, transformations and shipments, with the product description, quantity and unit.
Let the controls look
A lot shipped to the United States without a code, or with incomplete key data elements, opens a finding.
Run the check and the report
The FSMA 204 evidence check, and the traceability records report, signed.
The features it uses
The platform's features as they are; your products, units and certificates are settings.
- Lots and lineageRegister, deliver, split and process lots, and trace every kilogram back to the farm.
- DeliveriesHand lots to customers, warehouses and processors, checked by your lot rules before anything moves.
- Certificates and evidenceCertificates and lab results on each lot, with who stands behind each one.
- Lot rulesChecked before anything moves: allowed receivers, required certificates, expiry.
- AutomationsWhen something happens, and only if your conditions hold, prepare the next step for review.
- Humboldt, the AI analystExplains findings in business words and suggests next steps. People decide.
- Network and sharingConnect suppliers and customers, share evidence lot by lot and request what is missing.
- Reports and the audit packDashboards, reports and a signed audit pack anyone can verify without an account.
The industries it applies to
The evidence it produces
What a buyer, an auditor or a verifier you allow can read, with who declared each part.
- Traceability lot codes
- The code on each lot, with where it was assigned.
- Key data elements
- The key data elements of every receipt, transformation and shipment, kept with the code.
- FSMA 204 evidence check
- Requirement by requirement: recorded, missing, not applicable or not verifiable here.
- Lineage
- Each lot back to its inputs and their plots or farms, and forward to every holder.
- Recall scope
- Every lot, holder and quantity a recall reaches.
- EPCIS and UNTP
- Lot events as EPCIS 2.0, and the UNTP product passport of a lot.
An evidence check lists what the records hold. It is not a legal opinion and never says that a lot complies.
See your FSMA 204 records in a sandbox.
Tell us which foods you handle and where they go. We will show the check on your own lots.