OOO "Elanders" – FDA Warning Letter, Jul 12, 2022

The FDA issued a warning letter to OOO “Elanders,” a seafood processing facility in Riga, Latvia, following an inspection conducted on July 11-12, 2022. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations under Title 21, Code of Federal Regulations (21 CFR Part 123). The primary issues identified include inadequate hazard analysis and HACCP plans for ready-to-eat (RTE) refrigerated vacuum-packed cold smoked mackerel and salted herring fillets in marinade. Specifically, the HACCP plans failed to address critical food safety hazards such as pathogen growth, toxin formation, and allergens. Additionally, the plans did not identify critical control points or establish adequate critical limits to manage these hazards effectively.

The FDA requires OOO “Elanders” to conduct a thorough hazard analysis for each fish product and revise their HACCP plans to include all reasonably likely food safety hazards and critical control points. The plans must also define critical limits to prevent hazards like Clostridium botulinum growth and histamine formation. The company must submit a written response within 15 working days, detailing corrective actions and providing documentation, such as revised HACCP plans and monitoring records. Failure to comply may result in further regulatory actions, including the refusal of product entry into the U.S. under section 801(a) of the Federal Food, Drug, and Cosmetic Act.