FDA WARNING_LETTER - Comercializadora Internacional Piscicola New Your S.A - May 29, 2023

The FDA issued a warning letter to the seafood processing facility located at Km 15 Via Al Sur Vereda, Rio Frio Rivera, Huila, Colombia, operated by Mr. Ruiz. The inspection, conducted remotely from May 23 to May 29, 2023, identified significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123. The primary issues included the absence of a comprehensive hazard analysis and HACCP plan for their fresh and frozen tilapia products, failing to list Clostridium botulinum as a biological hazard, and inadequate labeling regarding storage requirements. Additionally, the facility"s HACCP plan did not address potential hazards from aquaculture drugs and environmental contaminants associated with receiving live fish.

The FDA requires the company to respond within 15 working days, detailing corrective actions and providing documentation such as a revised HACCP plan and monitoring records. Failure to comply may result in further actions, including the refusal of admission for imported products under Section 801(a) of the Federal Food, Drug, and Cosmetic Act, potentially leading to detention without physical examination (DWPE).

The company is urged to ensure compliance with the Act and all relevant regulations, including the seafood HACCP and Current Good Manufacturing Practice regulations. The response should be directed to Sheena Phillips, Compliance Officer, with reference to CMS # 672013. Further inquiries can be addressed to Ms. Kapoor via email.