US FDA Seafood HACCP: 2026 Guide For Indonesian Exporters

A practical playbook—exactly which HACCP and supporting records your US importer expects before first shipment, how to package them for FSVP review, and the formatting, language, recency, and signature details that prevent rework.

If you ask ten US importers what they need from an Indonesian seafood supplier before the first shipment, you’ll hear a version of the same thing: “A clean, reviewable HACCP package we can file under FSVP.” We’ve sat on both sides of that review, and the fastest approvals always come from suppliers who send the exact records importers expect—organized, signed, recent, and in English.

Here’s our 2026 pre‑shipment documentation playbook. It’s built from FDA 21 CFR 123 requirements and what US buyers are asking for right now.

The pre‑shipment HACCP document package importers actually want

Send one zipped folder with these items. When we follow this sequence, FSVP reviews move 30–50% faster.

1. Cover letter and supplier assurance

• One page on letterhead confirming your facility complies with FDA 21 CFR 123 (Seafood HACCP) and 21 CFR 117 Subpart B (cGMPs). Include site address, FDA registration number, and contact for QA.
• List the product families you will ship. Example: tuna items like Yellowfin Saku (Sushi Grade) and Yellowfin Steak; whitefish such as Grouper Fillet (IQF) or Goldband Snapper Fillet; crustaceans like Frozen Shrimp (Black Tiger, Vannamei & Wild Caught).

2. Current Seafood HACCP plan(s)

• Include product description, flow diagram, hazard analysis, HACCP table (CCPs, critical limits, monitoring, corrective actions, verification, records). Last revision date within the past 12 months. If you separated plans by species/form (e.g., tuna for raw/sashimi vs tuna for cook), send each plan.

3. Sanitation SOPs and recent sanitation monitoring records

• Show procedures that cover the 8 areas in 21 CFR 123.11. Provide 14–30 consecutive days of completed sanitation monitoring logs with signatures and any corrective actions.

4. HACCP monitoring logs (recent runs)

• 30 consecutive production days or 3–5 consecutive lots for each relevant product family. Include receiving temperatures, storage temperatures, time/temperature controls during processing, and packaging/freezing checks. Add thermometer calibration records covering the same period.

5. Verification records

• Daily or weekly record review sign‑offs by a trained individual. Annual HACCP reassessment record signed and dated. Any internal audits or CCP verification activities (e.g., scale or metal detector checks if applicable to your operation).

6. Training evidence

• Seafood HACCP Alliance (SHA) certificates for your HACCP coordinator(s). Keep the course breakdown if you used the blended online format (Segment 1 + Segment 2). Include an internal training matrix for operators and monitors if you have one.

7. Product‑specific test results and COAs

• Histamine COAs for scombrotoxin‑forming species (e.g., Yellowfin Saku, Bigeye Loin, Bigeye Steak). Provide per‑lot results and sampling approach.
• Pathogen and indicator results commonly requested for shrimp and raw fish for cooking: Salmonella, Vibrio parahaemolyticus/V. vulnificus (as specified by buyer), and APC. For RTE or sashimi items, buyers may ask for Listeria environmental swabs or parasite control records (freezing conditions) depending on your plan.
• Residues as contractually required. Many buyers request antibiotics screens for farmed shrimp and histamine for tuna even when not mandated by regulation.

8. Supplier and harvest controls (when risk‑based)

• For histamine control, include harvest vessel temperature practices or a supplier assurance letter for scombrotoxin control. For aquaculture, include farm origin and feed/chemical controls if your buyer requests them.

9. Document index

• A one‑page index mapping file names to plan sections. This single page reduces email back‑and‑forth more than anything else we send.

Practical takeaway: If your package above totals fewer than 20 files and every file has a clear date and signature, you’re probably in great shape for an FSVP desk review.

Formatting, language, signatures, and file naming that pass first time

In our experience, reviewers reject more packets for sloppy formatting than for science. Here’s how to package it so they can say “yes” quickly.

• Language. English or bilingual is fine. If your working language is Bahasa Indonesia, provide an English version or a bilingual template and add a short translator’s accuracy statement on the cover page. Keep hazard terms and CCP names in English.
• File format. Flattened, non‑editable PDFs. Avoid sending live spreadsheets unless requested. If you use e‑systems, export final, signed PDFs.
• E‑signatures. Scanned wet signatures or platform e‑signatures are commonly accepted for HACCP and sanitation records. Make sure each record shows printed name, job title, signature or electronic signoff, and date/time. If it’s typed only, add a statement like “By typing my name I attest this record is accurate” and keep unique user IDs behind the scenes.
• Recency expectations. Plans revised within the last 12 months. Monitoring and sanitation logs from the last 30 production days. COAs from the last 3–5 lots. Thermometer calibrations current to your SOP, typically monthly or quarterly.
• File naming. Use a predictable pattern: Company_Site_ProductFamily_DocType_YYYYMMDD_v#.pdf. Example: FoodHub_Surabaya_Tuna_HACCPPlan_20260115_v3.pdf. Put all test COAs in a subfolder named “COA_2026Q1”, and include a one‑page index.
• Record retention. 21 CFR 123.9: keep at least 1 year for refrigerated perishables and 2 years for frozen or preserved product. We keep digital backups for 4 years because FSVP audits often look back beyond 2 years.

Need help tailoring this packet to your exact products and buyer requests? We’re happy to review a draft and point out gaps. The fastest way to reach our QA team is to Contact us on whatsapp.

Quick answers to the questions we get most

What exact HACCP documents should I send my US importer before our first seafood shipment?

The nine‑item package above. If you’re prioritizing, send the HACCP plan, 30 days of HACCP and sanitation logs, SHA certificate, annual reassessment, and the relevant COAs. Most importers can prelim‑approve you with those five while the rest follow.

Do my HACCP plan and records need to be in English, or is bilingual acceptable?

Bilingual is fine. The importer must be able to understand and keep records for FSVP, so English must be present. A brief translator accuracy statement reduces pushback.

How many days or batches of monitoring and sanitation records do importers usually ask for?

We see 30 consecutive production days or 3–5 lots most often. For histamine‑prone species like tuna, some buyers ask for 5 consecutive lots with receiving temperatures plus histamine COAs. For shrimp, 3 lots of microbiological COAs is common.

Will a Seafood HACCP Alliance (SHA) online certificate satisfy FDA’s trained individual expectation?

Yes, when it includes the practical Segment 2 session. Send the certificate and note the date and provider. FDA doesn’t “approve” providers, but SHA certificates are widely recognized in inspections and FSVP audits.

Are scanned PDFs with electronic signatures acceptable for FDA and FSVP reviews?

Yes. FDA inspectors and FSVP reviewers accept scanned or e‑signed records as long as they’re legible, dated, and attributable. The weak spot is editable spreadsheets with no signoff—export to PDF and include sign/initial lines.

Which product‑specific test results do US importers commonly require?

• Tuna, wahoo, mackerel, and similar: histamine per lot, plus time/temperature receiving logs and vessel controls. Applies to items like Yellowfin Saku and Wahoo Portion (IQF / IVP / IWP).
• Shrimp: Salmonella, Vibrio profile as negotiated, and (for farmed) antibiotic residue screens per customer program. See Frozen Shrimp (Black Tiger, Vannamei & Wild Caught).
• RTE or sashimi‑intended fish: Listeria environmental results or parasite control evidence (freezing parameters), depending on your HACCP plan and buyer spec.

How often should I update and resend my HACCP documentation package to US buyers?

• Annually for your plan and reassessment page. Immediately after any material change to process, equipment, suppliers, or hazards.
• Each shipment or lot for COAs when required by the contract.
• Quarterly for sanitation and HACCP log samples if your buyer runs ongoing supplier verification. Many importers do a light quarterly review and a deeper annual review.

Common mistakes that slow approvals (and how to avoid them)

• Out‑of‑date plan. A 2023 revision date in 2026 is an instant slowdown. Re‑date after your annual reassessment and capture the reason for the review, even if “no changes.”
• Missing verification signatures. Logs without monitor initials and QA verification signoff are treated as incomplete. Train your team that “no signature” equals “not done.”
• COAs without lot linkage. Put the production date, lot code, and product description on the COA to match the finished goods label. If you rename lots for export, add a cross‑reference table.
• English file names but Bahasa logs. Bilingual is fine, but the signer names, CCP titles, and corrective action notes should be understandable to a reviewer. We often add a one‑line English summary in corrective action boxes.
• Unclear scope. If your plan covers both sashimi and cook‑only products, label which logs and COAs support which SKU families. For example, separate folders for tuna sashimi blocks versus tuna steaks for cooking (Bigeye Steak).

A note on aligning documentation with your products

Our buyers appreciate when our documents mirror the product line they’re onboarding. If you’re sending Grouper Fillet (IQF) and Red Snapper Portion (WGGS / Fillet), put those names in the product description page of your HACCP plan and in the COA headers. For tuna items like Yellowfin Saku or Bigeye Loin, include a brief note on your scombrotoxin controls at receiving and in cold storage with histamine COAs attached. It sounds small, but it tells a reviewer you control the hazards specific to the items they’ll actually buy.

Final takeaways you can use this week

• Build the nine‑item packet once and keep it evergreen. Update the plan annually, drop in the latest 30 days of logs, and rotate in fresh COAs as lots change.
• Keep everything in English or bilingual, signed, dated, and flattened to PDF. Use a predictable file‑naming pattern and a one‑page index.
• For tuna, think “5 lots histamine + temps.” For shrimp, think “3 lots micro/residues.” Send those COAs early to shorten onboarding time.

If you’d like examples of how we package records for complex lines like Yellowfin Saku alongside cook‑only fillets such as Mahi Mahi Fillet, we can share redacted samples and coach your team through the first submission. When you’re ready to review specifications and volumes, you can also View our products to match documents to SKUs you plan to export next.