FSMA 204 guide
Audit-ready traceability that lowers business risk
An industry study by the Food Marketing Institute and the Grocery Manufacturers Association put the average direct cost of a food recall at about US$10 million – before lost sales and brand damage. The size of a recall depends on how precisely you can say which cases are affected. Lot-level records in Producepak make that answer small and fast.
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24 h FDA traceability spreadsheet from one search
What auditors ask for – and get
| Auditor question | Producepak answer |
|---|---|
| Show me a mock recall | Forward and backward trace of any lot, timed, with the spreadsheet attached |
| How do you identify FTL foods? | FTL flag per item, listed in the traceability plan |
| Where is your traceability plan? | Stored in Producepak with its review history |
| Show records from 18 months ago | Kept for at least 2 years, searchable by lot, date or customer |
| How do you know every case was scanned? | Shipments cannot close with unscanned cases; exceptions are logged |
How it reduces risk
- Narrower recalls: withdraw the affected lots, not a week of production
- Faster answers: customers and FDA get facts in minutes
- Fewer rejections: retailers see complete PTI labels and ASNs
- Evidence for claims: QC photos and temperatures linked to each lot
- Less key-person risk: the process lives in the system, not in one person’s head
Mock recall in four steps
- Choose a lot Any lot code, or let the auditor pick one.
- Trace forward Every case, pallet, customer and delivery date that lot reached.
- Trace back Every field, harvest date, grower and input lot behind it.
- Export and file Spreadsheet and summary saved with the time it took – evidence for the next audit.
Questions
Does Producepak make us compliant on its own?
No software makes a business compliant on its own: you still decide which foods are covered, write the plan and make sure people scan. Producepak captures and keeps the records the rule asks for and produces them on demand.
Does this help with retailer and GFSI audits too?
Yes. The same lot records, mock recalls and QC history answer retailer, PrimusGFS, SQF and BRCGS traceability questions.
Sources and further reading
- fooddive.com – what a recall truly costs (FMI/GMA study: about US$10 million direct cost)
- fda.gov – FSMA final rule on requirements for additional traceability records
- producemarketguide.com – Walmart traceability requirement for leafy greens suppliers (2018)
- producepak.com – Producepak Fresh Produce App specifications (PDF)
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.