Issued to Ocean Group Inc.. Serious post-market compliance violation.
Issued
March 3, 2026Product
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Company
Ocean Group Inc.
Review center
CFSANStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Ocean Group Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Quality systems and CAPA, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on March 3, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.