FSMA 204
FSMA 204 compliance software for fresh produce
The FDA Food Traceability Rule requires key data elements for every critical tracking event on listed foods, and records within 24 hours of a request. Producepak captures them automatically as you receive, pack, transform and ship.
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Free setup & training · Human support by named fresh produce consultants
99% fewer shipping errors
95% less produce waste with precise inventory control
90% lower administration costs
US$6,200 a year – all modules, 8 users, unlimited sites
Key dates and scope
| Item | Detail |
|---|---|
| Rule | Requirements for Additional Traceability Records for Certain Foods (21 CFR Part 1, Subpart S) |
| Compliance date | 20 July 2028 (extended from 20 January 2026) |
| Foods covered | Food Traceability List – e.g. leafy greens, cucumbers, peppers, tomatoes, melons, tropical tree fruits, herbs, sprouts, fresh-cut fruit and vegetables, shell eggs, finfish, crustaceans, molluscs |
| Record request | Provide records within 24 hours; an electronic sortable spreadsheet when requested |
| Traceability plan | Written plan describing procedures, lot-code assignment and a point of contact |
The FDA Food Traceability Rule requires key data elements for every critical tracking event on listed foods, and records within 24 hours of a request.
Critical tracking events in Producepak
| CTE | Producepak record |
|---|---|
| Harvesting | Harvest data at receival or from the farm app |
| Cooling | Cooling event on the lot |
| Initial packing | Packing run with traceability lot code |
| Shipping | Dispatch scan: customer, PO, location, date, carrier |
| Receiving | Receival scan with supplier, TLC and source |
| Transformation | Batch inputs and new TLC for outputs |
What to do now
- Check which of your products are on the Food Traceability List
- Decide where you assign traceability lot codes
- Make sure suppliers send KDEs with each shipment
- Run a mock recall and time how long a sortable spreadsheet takes
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Questions
When is the FSMA 204 compliance date?
20 July 2028. FDA extended it from 20 January 2026.
Is all fresh produce covered?
No – only foods on the Food Traceability List, such as leafy greens, tomatoes, peppers, cucumbers, melons, tropical tree fruits, herbs and fresh-cut produce. Apples, citrus, bananas, potatoes and onions (whole) are not listed.
What is a traceability lot code?
A code assigned when food is initially packed, received by the first land-based receiver, or transformed, and recorded at every later shipping and receiving event.
FSMA 204 with Producepak
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