FDA WARNING_LETTER - Ocean Group Inc. - September 17, 2025

Ocean Group Inc. received a formal warning letter from the FDA following inspections of its seafood processing facilities in Los Angeles, Las Vegas, Dallas, and Oceanside between May and September 2025. The inspections revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations and the Federal Food, Drug, and Cosmetic Act. A primary concern is the recurring presence of Listeria monocytogenes in three of the facilities. Genetic testing linked these samples to previous facility isolates and human illnesses dating back several years, suggesting the presence of a persistent, resident pathogen. Specific sanitation failures included the use of damaged and filthy equipment, improper hand hygiene among employees, and cross-contamination risks from dripping condensate and uncleaned tools. Furthermore, the FDA found that the company’s sanitation monitoring records were often incomplete, pre-filled, or retroactively adjusted, rendering them unreliable. While the company submitted several responses detailing corrective measures, the FDA deemed these efforts inadequate because they lacked supporting evidence and failed to address the root causes of contamination. Ocean Group Inc. must provide a detailed written response within 15 working days outlining specific steps to eliminate the pathogen and ensure future compliance. Additionally, the company is required to attend a regulatory meeting on April 1, 2026, to discuss its corrective action plan and the potential for legal action if these safety issues are not resolved.