Warning Letter Record: Stavis Seafoods, LLC (2026-04-15) — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Letter issued · posted to fda.gov .
Subject as published: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
TL;DR
The short version: FDA issued a Warning Letter to Stavis Seafoods, LLC on 2026-04-15 citing: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stavis-seafoods-llc-727785-04152026
Argus analysis
Stavis Seafoods, LLC (MARCS-CMS 727785) received an FDA Warning Letter dated April 15, 2026 from the Office of Inspections and Investigations. The letter cites: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 2, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Stavis Seafoods, LLC MARCS-CMS 727785 — April 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Juan Lopez Martinez Recipient Title CEO Stavis Seafoods, LLC 1 Seafood Way Boston , MA 02210-2702 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States 04/15/2026 WARNING LETTER RE: CMS# 724267 Dear Mr. Martinez: On February 03, 2026, through February 05, 2026, the Food and Drug Administration (FDA) conducted an inspection of your seafood importer establishment, Stavis Seafoods, LLC located at 1 Seafood Way, Boston, MA 02210-2702. We also conducted an inspection from June 11 through June 13, 2024. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your frozen aquaculture salmon fillets are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov. Your significant violations are as follows: You do not have or have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). Specifically, your firm did not implement an affirmative step for ensuring that the frozen aquaculture salmon fillets you import from (b)(4) located in (b)(4) are processed in compliance with the Seafood HACCP regulation. We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without phy…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Has Stavis Seafoods, LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Stavis Seafoods, LLC as of 2026-06-02. Argus ingests new FDA enforcement records daily.
- What FDA violations was Stavis Seafoods, LLC cited for?
- The FDA Warning Letter to Stavis Seafoods, LLC (issuing office: Office of Inspections and Investigations) cites: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Stavis Seafoods, LLC?
- FDA issued the letter (MARCS-CMS 727785) on 2026-04-15 and posted it publicly on fda.gov on 2026-06-02.
- Is the FDA warning letter to Stavis Seafoods, LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stavis-seafoods-llc-727785-04152026.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Warning Letter Record: Stavis Seafoods, LLC (2026-04-15) — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-stavis-seafoods-llc-2026-04-15-cgmp
"Warning Letter Record: Stavis Seafoods, LLC (2026-04-15) — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-stavis-seafoods-llc-2026-04-15-cgmp.
Argus HQ Research. "Warning Letter Record: Stavis Seafoods, LLC (2026-04-15) — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-stavis-seafoods-llc-2026-04-15-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_stavis_seafoods_llc_2026_04_15_cgmp_2026,
title = {Warning Letter Record: Stavis Seafoods, LLC (2026-04-15) — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-stavis-seafoods-llc-2026-04-15-cgmp},
note = {Accessed: July 13, 2026}
}