FSMA 204 Traceability Lot Code (TLC) Worksheet
FSMA Section 204 requires certain businesses that handle foods on the FDA Food Traceability List to keep records at critical tracking events, tied together by a traceability lot code. This worksheet gives you the rows and columns to practise the discipline now.
| Critical tracking event | Food and variety | Traceability lot code | TLC source (location or reference) | Cases | Units per case | Total units | Event location | Event date | Reference document | |
|---|---|---|---|---|---|---|---|---|---|---|
2,880 | ||||||||||
3,600 | ||||||||||
1,800 | ||||||||||
1,800 | ||||||||||
480 |
Which events and data elements apply depends on your role (grower, packer, shipper, receiver, transformer, retail) and on whether the food is on the FDA Food Traceability List. FDA has extended the compliance date to July 2028, so confirm the current date and exemptions in the rule text. Records must be producible within 24 hours of a request, as an electronic sortable spreadsheet.
Generate FSMA 204 records from your ERP
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How to use the worksheet
Add one row per event per lot. Pick the critical tracking event, enter the food and variety, the traceability lot code, the location or reference that identifies where the code was assigned, the quantity and unit of measure, the event location and date, and the document that proves it. Receiving rows should repeat the supplier lot code, and transformation rows should show the new lot code. Export to Excel or CSV and sort by lot code to see a lot's journey, which is the same exercise FDA will ask you to do on request.
What the rule asks for
The Food Traceability Rule (21 CFR Part 1, Subpart S) requires key data elements linked to critical tracking events for foods on the Food Traceability List, such as leafy greens, fresh-cut fruits and vegetables, soft cheeses, finfish, shell eggs, fresh herbs and some others. The traceability lot code identifies a lot at the point it is initially packed, received first from a fishing vessel or transformed. It must be passed on to the next customer. Covered entities also need a traceability plan and must supply an electronic sortable spreadsheet within 24 hours when FDA requests it during an outbreak.
Reading your data
Sort by TLC and check that every lot has a source event and that quantities reconcile: cases received should explain cases transformed, shipped and held. In the example, 300 cases of salad kit were made and 300 shipped in two loads, which reconciles. Gaps show up as a lot that was shipped but never received, a transformation row with no input lot, or a shipping row with no reference document. Those are the same holes a mock recall exposes.
- Every lot needs a source event
- Quantities should reconcile across events
- Every row needs a reference document
- New lot codes at transformation must link to input lots
Common mistakes
Teams confuse the TLC with the supplier's lot or a best-before date, and reuse the same code for different production runs. Others record the ship-to location but not the TLC source, or store records across email, paper and the ERP so nothing can be produced in 24 hours. The practical fix is to generate TLCs inside the ERP, print them on the label and carry them on the ship notice, so the spreadsheet is a report rather than a manual task.
Frequently Asked Questions
What is a traceability lot code?
It is a descriptor, often alphanumeric, that identifies a traceability lot. It is assigned when a food is initially packed, first received from a fishing vessel, or transformed, and it must be provided to the next recipient.
Does FSMA 204 apply to my product?
It applies to foods on the FDA Food Traceability List, plus foods that contain them as ingredients when specific conditions apply. Some exemptions exist for small producers, certain retail transactions and some other cases. Check the rule and the list on the FDA site.
What is the compliance date?
FDA extended the original January 2026 date to July 2028. Dates and enforcement positions can change, so verify on the FDA website before planning a rollout.
Do I need special software?
The rule does not require specific software. You must keep the records and be able to give FDA an electronic sortable spreadsheet within 24 hours. An ERP lot tracking module or a well kept spreadsheet can both work at small scale.
If your ERP already holds lot, work order and shipment data, we can help generate this traceability spreadsheet directly from it so you are not rekeying events.
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