FSMA 204 traceability, built in
FDA's Food Traceability Rule (FSMA 204) requires lot-level records for foods on the Food Traceability List — and the ability to hand them to the FDA within 24 hours. CDXAI captures those records inside the transactions that already run your business, so compliance isn't a separate system to maintain.
Under FSMA 204, distributors handling listed foods have to record specific Key Data Elements (KDEs) at specific Critical Tracking Events (CTEs) — receiving, shipping, and transformation — and produce a sortable record on request. The rule's compliance date is January 20, 2026. The distributors who struggle with it are the ones treating traceability as a reporting project bolted onto systems that were never designed to carry a lot code from receiving through to the customer's dock.
CTEs and KDEs captured automatically
In CDXAI, the Critical Tracking Events are the same events that already move your product. When your warehouse receives a pallet, ships an order, or transforms a product in manufacturing, the platform records the traceability lot code, the location, the date, the quantity, and the reference documents — automatically, at the moment the work happens. There's no after-the-fact data entry and no separate compliance module to reconcile against the operation.
Forward and backward trace in seconds
Because every movement is linked to its lot, a trace is a query, not a fire drill. Pick any lot and CDXAI walks it backward to the supplier and inbound shipment, and forward to every customer order it shipped on. What used to mean pulling records from an accounting system, a warehouse system, and a spreadsheet — and hoping they matched — is a single, sortable result you can export.
Answering a 24-hour FDA request
When the FDA issues an information request, the clock is 24 hours. CDXAI produces the sortable spreadsheet of traceability records the rule describes, filtered to the lots, dates, and locations in scope, in one export. You can also run mock-recall drills against real data on a schedule, with built-in completion tracking, so the first time you do it isn't during an actual recall.
Beyond the trace: the rest of the FSMA picture
Traceability is the headline, but FSMA compliance is broader. CDXAI also handles Food Traceability List classification across the FDA's categories, Foreign Supplier Verification (FSVP) with re-evaluation cycles, FDA registration and biennial renewal, and recall management across Class I–III. It sits alongside allergen segregation and cold-chain monitoring in the same warehouse system, so food-safety data travels with the lot rather than living in a parallel binder.
Most ERP and WMS vendors treat traceability as a checkbox. If a hard FDA deadline is bearing down on your operation, the difference between a checkbox and a built-in capability is the difference between a clean audit and a scramble.