A practical, first‑load checklist to satisfy 21 CFR 123.12. What to request from your foreign seafood processor, how to document affirmative steps for histamine species, what FDA expects during inspection, and how often to re‑verify suppliers.
If your first US shipment is weeks away, you probably don’t want theory. You want the exact packet FDA will ask for when they show up. We’ve built hundreds of these with US buyers and foreign processors. In our experience, a clean 21 CFR 123.12 file is the difference between a calm inspection and a long day of scrambling.
We’ll stay tightly on importer verification records. Not SIMP, HTS, health certificates, temperature logger decisions, glaze or co‑loading. Just the verification you owe as an importer under Seafood HACCP.
The quick difference: FSVP vs Seafood HACCP importer verification
Seafood importers usually aren’t under FSVP. Fish and fishery products fall under Seafood HACCP. That means you must meet 21 CFR 123.12. The obligation is simple on paper. Take affirmative steps to verify that each foreign processor has and implements a compliant HACCP system and sanitation controls. In practice, FDA expects a tidy, product‑specific file before your first load arrives.
The 3 pillars of a 21 CFR 123.12‑ready file
- Supplier‑specific HACCP proof. Not generic certificates. Actual evidence the foreign processor’s HACCP plan fits your product and hazards.
- Sanitation controls and implementation. Written SSOPs plus recent monitoring records. FDA looks for proof of implementation, not just a policy.
- Risk‑based “affirmative steps,” especially for histamine species like tuna, mahi and wahoo. If you import Yellowfin Saku (Sushi Grade), Yellowfin Steak, Bigeye Loin, Mahi Mahi Fillet or Wahoo Portion, you’ll need to be more specific about temperature and testing controls across harvest and receipt.
Week 1–2: Build the core packet before you book space
Here’s the FDA‑friendly list we request up front. It’s what record reviewers actually use.
- Foreign supplier details. Legal business name, address, FDA FURLS number if available, plant code, contact person.
- Product‑by‑product HACCP plan and hazard analysis. Match your exact item. Example. Yellowfin tuna saku, frozen, vacuum packed, intended for raw consumption.
- Flow diagram and product description. With packaging format and intended use noted.
- SSOPs and at least 3–6 recent sanitation monitoring records. One week of records is common. Show cleaning, handwashing, pest control, water/ice safety.
- Letter of guarantee. Should state the processor complies with 21 CFR 123 and 110/117, list covered products, and assert the HACCP plan is implemented and reassessed as needed. Signed and dated on company letterhead. A broker letter won’t satisfy FDA.
- Labels and finished‑product specs. Include storage conditions and shelf life. If your brand is used, include your label.
- For histamine‑forming fish. Evidence that the HACCP plan covers scombrotoxin hazards from harvest through receipt. Common proofs include landing temperature control procedures, receiving critical limits, and histamine testing procedures with action limits.
If you’re buying from us, we map this packet to the specific item. For example, a US buyer of Mahi Mahi Portion (IQF) gets a different hazard analysis emphasis than someone importing Yellowfin Saku (Sushi Grade). Same structure. Different hazards.
Practical takeaway. Before you book the first container, send a one‑page request listing these items and a deadline. Most solid processors can deliver within 2–3 weeks. If they can’t, that’s your first risk signal.
Week 3–6: Document your affirmative steps and test your inspection readiness
21 CFR 123.12 lists acceptable “affirmative steps.” We see five that consistently satisfy FDA when they’re well documented.
- Obtain and review the supplier’s HACCP plan, hazard analysis, and SSOPs. Keep a dated review note in your file that shows you read it and found it adequate for your product and market. Two paragraphs are enough if they are specific.
- Keep copies of recent sanitation and critical control monitoring records. For example, receiving temperature logs, histamine test logs, freezer control charts.
- Get a continuing or lot‑by‑lot certificate from an appropriate government authority that specifically attests to compliance with US Seafood HACCP. Generic export health certificates don’t count.
- Commission or obtain a recent on‑site audit that evaluates compliance with 21 CFR 123. It needs to explicitly reference Seafood HACCP criteria, not just ISO or BRC generalities.
- Use a third‑party inspection report that evaluates HACCP implementation for your products. Again, it must tie to 21 CFR 123, not only Codex.
You don’t need all five. One strong path plus supporting records is fine. In our experience, importers of histamine species do best with this package. Full HACCP plan and hazard analysis. Receiving temperature monitoring records. Histamine test procedure and recent results. A letter of guarantee that references scombrotoxin controls.
Here’s the inspection‑day mini‑checklist we rehearse internally.
- Tab 1. Supplier info and organizational chart contact.
- Tab 2. HACCP plan and hazard analysis. Dated and signed.
- Tab 3. SSOPs and one week of recent sanitation records.
- Tab 4. Affirmative step evidence. Your review memo, recent monitoring records, any audit or government attestations.
- Tab 5. Product specs, labels, and intended use. If raw consumption is intended, that should be clear.
- Tab 6. Re‑verification schedule and last re‑assessment note.
If your products span species types, separate tabs per item. For example, keep Cobia Fillet (IVP / IQF) apart from Yellowfin Steak because hazards differ.
Do I need the foreign processor’s full HACCP plan, or is a letter enough?
Get the plan. In the last six months, we’ve seen more 483s citing “failure to obtain and review the foreign processor’s HACCP plan.” A letter of guarantee is useful, but FDA wants evidence that you reviewed a plan that fits your product and hazards. A letter without the plan isn’t a safe bet.
What counts as an “affirmative step” for tuna, mahi and other histamine fish?
Concretely. Your file should show the supplier’s receiving critical limits and monitoring frequency. Proof they control time and temperature from landing to processing. Histamine testing SOPs and recent results if their plan uses testing as verification. For Bigeye Steak or Yellowfin Saku (Sushi Grade), confirm the plan addresses raw consumption and histamine.
Can a third‑party audit or government certificate replace the HACCP and SSOP documents?
Only if it explicitly evaluates compliance with 21 CFR 123 and confirms the supplier has and implements a HACCP plan appropriate to your products. Generic GFSI or ISO certificates don’t satisfy 123.12. Many government export certs are product‑safety documents, not HACCP attestations. Read the wording.
Will my customs broker handle seafood HACCP importer verification for me?
Brokers rarely own this obligation. Some will collect documents as a service, but FDA holds the importer of record responsible. Keep the packet in your own quality system.
Week 7–12: Re‑verify and harden your process
How often should you re‑verify? Our rule of thumb. Annually for low‑risk items and suppliers with strong history. Every 6–12 months for histamine‑forming fish or when switching seasons, fleets or plants. Immediately on any trigger event. Temperature abuse report, rejected lot, species substitution concern, change in product form or intended use.
Document your re‑verification in a simple memo. Reference the plan date, any changes, your risk conclusion, and what you checked. Two pages tops. Inspectors appreciate clarity more than volume.
Common pitfalls we still see (and how to avoid them)
- Letter of guarantee signed by a trader. FDA expects it from the foreign processor actually controlling hazards.
- HACCP plan that doesn’t match your product. For example, a cooked product plan used for your raw Yellowfin Saku (Sushi Grade).
- No proof of implementation. Policies without monitoring records. Include at least a recent slice of records.
- Vague review notes. Write a short importer review that mentions specific hazards and critical limits relevant to your item.
- Waiting until freight arrival. Build the file before the first booking. Three out of five issues we’re called to fix could have been solved two weeks earlier with a clean request email.
What happens at FDA inspection if your file is thin?
Expect a Form 483 observation for failure to take affirmative steps under 21 CFR 123.12. That can escalate to a Warning Letter if uncorrected, or scrutiny of future entries. In some cases, shipments are detained pending evidence of compliance. You can recover, but it is expensive and time‑consuming. Having a ready packet avoids that dance.
Quick answers to questions we get every week
- Is seafood covered by FSVP or Seafood HACCP importer verification? Seafood HACCP. 21 CFR 123.12, not FSVP, covers fish and fishery products.
- What documents do I need before the first shipment arrives? HACCP plan and hazard analysis matched to your product. SSOPs and recent monitoring records. Letter of guarantee. Product specs and labels. Affirmative step evidence like your review memo, and for histamine species, temperature and histamine controls.
- How often to re‑verify suppliers? Annually as a baseline. More frequently for higher‑risk items or on change events.
If you want a ready‑to‑audit packet for any item we produce, send us your SKU list and intended use. We’ll map hazards to the exact product. Need help with your specific situation? You can Contact us on whatsapp and we’ll walk through 21 CFR 123.12 line by line.
Resources and next steps
- Start with one product and build the template. Then replicate across your catalog.
- For histamine species like tuna, mahi and wahoo, double‑check time and temperature controls across harvest and receipt in the supplier’s plan. Ask for recent results if they run histamine testing.
- If you are evaluating multiple Indonesian suppliers, request the same packet from each and compare. Consistency wins. For reference examples, see our lines such as Yellowfin Steak, Mahi Mahi Fillet and Wahoo Portion. The hazards differ, and the files should too.
The reality is that FDA isn’t chasing perfection. They look for a thoughtful, risk‑based file that shows you know your products and your processors. Build that once and you’ll sleep better before every arrival.