2026-09-11 FDA Warning Letter: Ocean Pride Seafood, Inc. Cited for 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: The FDA issued a Warning Letter (CMS #730154) to Ocean Pride Seafood, Inc. on September 11, 2026, following an inspection of its Ventura, California facility from March 23–April 1, 2026. The agency found serious violations of seafood HACCP regulations (21 CFR Part 123), determining that the facility's ready-to-eat seafood products—including raw tuna, salmon, halibut, smoked salmon, and live shellfish—are adulterated due to preparation under insanitary conditions and failure to implement adequate HACCP plans and monitoring procedures. Specific deficiencies include: lack of monitoring records for product receiving since November 2022 and storage temperatures since December 2022; failure to implement listed monitoring procedures for histamine control in finfish and Clostridium botulinum control in smoked salmon; and revised HACCP plans that do not adequately identify or control pathogenic bacteria, histamine, and botulinum toxin hazards at critical control points.
Argus analysis
# FDA Warning Letter Analysis: Ocean Pride Seafood, Inc.
**Company and Findings**
Ocean Pride Seafood, Inc., a seafood processor located in Ventura, California, received a Warning Letter from FDA's Human Foods Program on September 11, 2026, following an inspection conducted March 23–April 1, 2026. FDA determined that the company's ready-to-eat seafood products—including raw tuna, salmon, halibut, smoked salmon, live shellfish, and imitation crabmeat—were adulterated due to preparation under insanitary conditions and failure to implement required safety controls. The inspection documented specific hazards including bacterial growth, histamine formation, Clostridium botulinum toxin, and parasites, with inadequate monitoring procedures across multiple product lines.
**Regulatory Citations**
The violations centered on 21 CFR Part 123 (Seafood HACCP regulation) and 21 CFR Part 117 (Current Good Manufacturing Practice). Section 123.6(b) requires documented monitoring procedures at Critical Control Points; the company lacked monitoring records since late 2022. Section 123.6(a) mandates hazard analysis for each product type; Ocean Pride's revised HACCP plans omitted pathogenic bacteria and histamine hazards at storage points. Section 123.7(b) requires adequate corrective actions addressing both product disposition and root causes; the company's corrective measures were incomplete. Section 123.11(b) mandates sanitation monitoring with records; no documentation existed from August 2023 through inspection date.
**Response and Industry Watch Points**
Ocean Pride submitted responses on April 1 and May 6, 2026, including revised HACCP plans that FDA deemed inadequate. Compliance officers should anticipate a follow-up inspection within 12–18 months. Key indicators include whether the company addresses species-specific HACCP plans, restores monitoring documentation systems, corrects facility sanitation (mold on ice machines, floor-washing practices), and implements robust corrective action protocols beyond simple product rejection.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
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 Ocean Pride Seafood, Inc. MARCS-CMS 730154 — September 11, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC DELIVERY Product: Food & Beverages Recipient: Recipient Name Thomas G. Moore Recipient Title CEO/Owner Ocean Pride Seafood, Inc. 2894 Bunsen Ave., Suite B Ventura , CA 93003-7682 United States oceanprideseafood@gmail.com Issuing Office: Human Foods Program United States September 11, 2026 WARNING LETTER Re: CMS #730154 Dear Mr. Moore: The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 2894 Bunsen Ave., Suite B, Ventura, CA 93003-7682, from March 23, through April 1, 2026. During our inspection, the FDA investigator found 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). Based on FDA’s inspectional findings we have determined that your ready-to-eat (RTE) seafood products: aquaculture raw tuna, aquaculture raw salmon, wild caught raw tuna, raw ono (wahoo), wild caught raw halibut, raw yellow tail tuna, raw cod, raw seabass, raw mahi-mahi, raw snapper; raw trout, raw amberjack loins, vacuum-packed sliced smoked salmon, vacuum-packed imitation crabmeat (surimi), scallops, pasteurized canned crabmeat, live mussels, live oysters, and live clams are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (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. Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with 21 CFR 123.6 whenever a HACCP plan is necessary or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA’s home page at www.fda.gov. At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility. You provided responses to the FDA-483 issued to you on April 1, 2026 and May 6, 2026. Your May 6, 2026, response included revised HACCP plans that are not adequate. We are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We address your response below. Your significant violations of the seafood HACCP regulation are as follows: 1. You must implement the monitoring procedures that you have listed in your HACCP plans for “histamine gr…
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
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- 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 is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Ocean Pride Seafood, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Ocean Pride Seafood, Inc. as of 2026-10-13. Argus ingests new FDA enforcement records daily.
argus.hq
Don’t find out about the next one six weeks late.
Argus reads every FDA Warning Letter the day it publishes, summarizes it against your watchlist, and lands the ones touching your business in your inbox at 6am ET. Plans from $99/month. Cancel any time.
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). 2026-09-11 FDA Warning Letter: Ocean Pride Seafood, Inc. Cited for Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ocean-pride-seafood-inc-2026-09-11-cgmp
"2026-09-11 FDA Warning Letter: Ocean Pride Seafood, Inc. Cited for Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ocean-pride-seafood-inc-2026-09-11-cgmp.
Argus HQ Research. "2026-09-11 FDA Warning Letter: Ocean Pride Seafood, Inc. Cited for Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions." Digital Empire Holdings LLC. Accessed October 14, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ocean-pride-seafood-inc-2026-09-11-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ocean_pride_seafood_inc_2026_09_11_cgmp_2026,
title = {2026-09-11 FDA Warning Letter: Ocean Pride Seafood, Inc. Cited for Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ocean-pride-seafood-inc-2026-09-11-cgmp},
note = {Accessed: October 14, 2026}
}