The FDA's Food Traceability Rule, better known as FSMA 204, was finalized in November 2022. It asks businesses that hold foods on the FDA's Food Traceability List to keep lot-level records of what they receive, ship and transform, and to hand those records to the FDA within 24 hours when asked. The compliance date is July 20, 2028: Congress directed the FDA not to enforce the rule before then, and the FDA has said it will follow that direction (FDA, Food Traceability Rule).
That is time, but not slack. Supplier conversations, receiving habits and picking changes take months to settle. This checklist is meant to be run on the warehouse floor with real paperwork, not in a meeting. Each item has a test. For the rule's field-by-field detail, read what critical tracking events mean for your software; for a plain overview, see our FSMA 204 guide.
How to run it
Pick one owner and one afternoon. Use documents from the last few weeks, not prepared examples. Mark each check pass, partial or fail, with one line on what the fix would take. Repeat every quarter.
Scope
1. Mark every covered item
Go through your active item list against the Food Traceability List and flag each covered item in your item records. Read each entry's wording rather than going by category name: the list separates fresh, fresh-cut and frozen forms, and it also covers foods that contain a listed food as an ingredient in the same form, such as a deli salad made with fresh produce.
Test: can anyone in the office tell, from the item record alone, whether an item is covered? A separate spreadsheet that goes stale does not count.
2. Write down any exemption you are relying on
The rule's exemptions mostly target small farms, small retail food establishments and restaurants, and foods that get a kill step under set conditions. Most distributors handling covered foods are covered.
Test: if you believe an exemption applies, you can name the section of the rule it comes from.
Suppliers
3. Know what each supplier will send
Under the rule, whoever ships a covered food must pass along its traceability lot code, quantity, product description, the locations involved, the ship date and where the lot code was assigned. Ask each supplier of covered items how that will reach you: printed on the case, on the bill of lading, in an advance ship notice or by email.
Test: for each supplier of covered items, you have a written answer.
One rule to settle early: a distributor that only receives and ships keeps the supplier's lot code. The FDA's own FAQ says a distributor should not change the code it was given. Your internal lot or receipt number is fine for running the warehouse, as long as it stays linked to the supplier's code.
Receiving
4. Capture the lot at the dock
For every receipt of a covered food, the rule lists eight key data elements, including the lot code, quantity and unit, the immediate previous source, the date and the reference document (such as the bill of lading number).
Test: take five receipts of covered items from last week. Find every element for each one in your system. If any of them lives only on a paper tally or in a free-text note, mark it partial.
Inside the building
5. Keep lots intact through moves and returns
Put-away and internal moves are not tracking events under the rule, but they decide whether your shipping records are true. A return restocked without its lot breaks the chain quietly.
Test: pick a lot received last month and ask where every case of it is now: on hand, shipped, returned or written off.
6. Treat repacking as transformation
The FDA's FAQ says repacking a covered food is always a transformation event, and relabeling and commingling are named in the rule's definition too. You record the input lots and quantities, assign a new lot code (a like-into-like repack may keep the code, with your site as the new lot code source), and record where, when and how much came out. Breaking down a pallet is holding, not transformation. If you only open a case and sell sealed, fully labeled inner packs, check the rule's definition or ask the FDA's Technical Assistance Network how it applies to your exact workflow.
Test: list every place your team repacks, cuts, relabels or mixes product. For each one, you can show the input lots and the output lot for a recent job.
Shipping
7. Tie every shipped line to a lot
This is the check most likely to need real work. If pickers record only quantities, you know the item a customer got but not the lot. The FDA does not require barcode scanning, but your method has to produce accurate lot records.
Test: pull a random invoice for a covered item from last week. Name the lot or lots on each line without asking the person who picked it.
8. Send customers what they need
Your customers keep their own receiving records, and most of what they need comes from you: the lot code, quantity and unit, product description, the ship-from and ship-to locations, the ship date and the lot code source.
Test: look at what leaves with a covered shipment. Every one of those elements is on it or sent with it.
Records and the plan
9. Produce records within 24 hours
Records can be paper, electronic or true copies, kept for two years from when you created or obtained them. During an outbreak, a recall or another public health threat, the FDA can ask for records for specific foods and dates as an electronic sortable spreadsheet, unless your business is under the rule's size thresholds for that requirement. The FDA's published template is optional.
Test: pick one covered item and a two-week window. Time how long it takes to produce every receiving and shipping record for it, with an explanation of any internal codes. Then run a full recall mock drill.
10. Write the traceability plan
Every covered business needs a written plan that describes how you keep the records and where they live, how you identify covered foods, how you assign lot codes (if you transform), and a point of contact. Update it when your practice changes and keep the previous version for two years.
Test: a new receiving lead could read the plan and do the job the way it describes.
What to fix first
Fix lot capture at receiving and picking first, because checks 5 through 9 depend on it. Then repacking, then retrieval and the plan. Train the people doing the work and spot-check their records afterwards; the FDA itself points to training, written procedures and spot checks as ways to keep lot data accurate.
Where APFoodz fits
In APFoodz, each lot's events are recorded as the work happens, so a trace forward or back is a lookup instead of a hunt through paper. Receiving and picking run in the warehouse app on iOS, Android or a Zebra handheld. More on traceability and recalls.