FSMA 204 guide
Section 204 records without extra paperwork
FSMA 204 asks for key data elements at every critical tracking event and an electronic sortable spreadsheet within 24 hours. In Producepak the data is captured by the scans your team already makes at receiving, packing and dispatch – so the spreadsheet is a search and an export, measured in seconds.
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24 h FDA traceability spreadsheet from one search
Key data elements for produce
| Key data element | Harvest | Cooling | Initial pack | Ship | Receive | Transform |
|---|---|---|---|---|---|---|
| Product description and variety | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Quantity and unit of measure | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Date of the event | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Location (field with coordinates at harvest) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Business name and contact | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Reference document type and number | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Traceability lot code (TLC) | ✓ | ✓ | ✓ | ✓ |
Cooling records apply when cooling happens before initial packing. Harvest location includes the field and its coordinates.
Where each record comes from in Producepak
| Event | What the team does | What Producepak records automatically |
|---|---|---|
| Harvest | Scan the bin tag in the field | Field and coordinates, grower, commodity, variety, quantity, date, picker crew |
| Cooling | Scan the bin into the cooler | Cooler location, date and time, linked harvest lot |
| Initial packing | Start the packing run, print labels | New TLC, source harvest lots, cases by product and size, pack date, line |
| Shipping | Scan pallets onto the truck | TLC per case and pallet, quantity, ship-to, carrier, BOL and ASN numbers |
| Receiving | Scan the inbound pallet labels | Supplier TLC, quantity, ship-from, date, PO and invoice numbers |
| Transformation | Run the repack or fresh-cut job | New TLC linked to every input lot and its quantity |
The spreadsheet, in seconds
- Search Enter a lot code, product, customer or date range.
- Trace Producepak follows the lot forward to every customer and back to every field.
- Export One click produces the sortable spreadsheet: one row per event, one column per key data element.
- Send Email it to FDA or your customer – within minutes, not the 24 hours allowed.
Why there is nothing extra to do
- No second system: traceability is a by-product of inventory, packing and shipping
- No retyping: lot codes travel in barcodes, ASNs and EDI
- No end-of-day logs: every scan is time-stamped
- No gaps: a case cannot ship without a lot
- Pak-Bot answers "where did lot X go?" in plain English
Questions
Does FDA require a specific format?
The rule requires an electronic sortable spreadsheet with the relevant traceability information; FDA offers a voluntary template. Producepak exports one row per event with each key data element in its own column, and can match a customer’s template.
What about data from suppliers who do not send lot codes?
Producepak assigns a TLC at receiving where the rule requires it and records the supplier’s documents as the reference, so the chain is not broken.
See Producepak running on your product
Watch the short video, then book a live demonstration with a fresh produce consultant who knows US packhouses, PTI labels and FSMA 204.