FDA WARNING_LETTER - Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ - June 13, 2023

The FDA issued a warning letter to Independent Seafoods Panama, S.A., operating as Panama Artisanal Seafoods FQ, following an inspection conducted on June 12-13, 2023, at their facility in Panama City, Panama. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123. The firm failed to develop and implement a HACCP plan for several seafood products, including grouper, snapper, amberjack, yellowfin tuna, mahimahi, mackerel, and stingray wings, which are associated with risks such as ciguatera fish poisoning, histamine toxin formation, and Clostridium botulinum.

The FDA emphasized that the absence of a HACCP plan renders these products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The company must conduct a hazard analysis and establish critical control points to manage food safety hazards effectively. The FDA requires a written response within 15 working days, detailing corrective actions, including revised HACCP plans and monitoring records. Failure to comply could lead to further actions, such as detention without physical examination of imported products.

The company is urged to ensure compliance with the Act and applicable regulations, including the seafood HACCP regulation and the Good Manufacturing Practice Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation. The response should be directed to Giselle Jordan, Compliance Officer, with reference #665705.