FDA rejected a Chicago importer’s February 2026 response because it acknowledged the violations and stated an intent to fix them, without documentation. What closes a §123.12 finding is the corrected file: a specification for every product, an identified affirmative step for every supplier-product, and records signed and dated at the time of the activity.
Your counsel writes the response. We build the file it points to. Month to month, no annual contract while you are responding.
“Your written verification procedures do not identify which affirmation step(s) you have chosen to implement.”
Chicago, Feb 2026A roster where the step is a required field per supplier-product. The printed procedures name it, and the evidence for it sits behind it.
Specifications “does not include parasite hazards, does not identify specific aquaculture drug hazards.”
Tilapia importer, May 2023, response rejected twiceSpecifications generated from the Guide’s hazard tables for that species and process, then signed by you. Not written from memory.
“… was not signed and dated at the time of the activity.”
Chicago, Feb 2026An append-only verification log with server-set timestamps and a named signer. A record cannot be backdated, so the question does not come up.
“A repeat observation from the previous inspection conducted 08/28/2019.”
Houston, May 2026Expiry sweeps and a standing readiness state per supplier-product, so the file is current in year three, not just in the fortnight after the letter.
Starting with the supplier-products the letter names, then the rest. Ben is on every call; Brett reviews the hazard mappings.
Everything you take title to at entry, with the affirmative step you actually rely on for each. Where there is none, that row is red until there is.
For each species and process, the hazards FDA expects, pre-filled for your review and signature.
Their HACCP plans read against the Guide, findings cited to chapter and table, and a cover note for the plant in their language so gaps get closed rather than argued.
Procedures, specs, steps, evidence and the signed log: the artifact your response attaches, and the one you produce again next year without rebuilding it.
Detention without physical examination applies to every subsequent entry from that combination. A petition for removal is evidence-driven: the processor’s plan and records, and your verification file for the pair. We build the second part with you and give the processor a free workspace to produce the first.
We do not quote removal timelines; FDA does not publish them and anyone who gives you one is guessing.
Under 21 CFR 123.10 a trained person must perform the hazard analysis and review the records. Every plan review here requires that person’s attestation before it can be exported or counted.
It reports what is on file and what is missing. It will not tell you, or FDA, that you meet a requirement. That is not a judgment software gets to make.
If the model cannot cite the Guide, it says it could not determine rather than inventing a control. The Guide edition used is stamped on every output.
Thirty minutes, this week. You will leave knowing which of the four findings you have, which supplier-products they touch, and what the file needs to contain. No charge for the call.
Keelsure is not legal advice and does not draft your response. It produces the documented file the response has to point to. Most firms have their lawyer on the first call, and that is the right way round.