FDA WARNING_LETTER - Pescaderia Catano - November 30, 2018

The FDA inspected a seafood processing and distribution facility in Cataño, PR, from November 3-30, 2018, and found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The facility processes fresh fish (e.g., Snapper, Tuna), mollusks (e.g., Conch), and crustaceans (e.g., Lobster).

Key violations include: - Failure to conduct a hazard analysis for each type of fish or fishery product to identify potential species-related and process-related hazards (e.g., Ciguatera Fish Poisoning, Scombroid Toxin). - Absence of written HACCP plans for various seafood products (e.g., Snapper, Tuna, Conch) to mitigate hazards at receiving, storage, processing, and distribution points. - Lack of monitoring or records to demonstrate that received products were not temperature abused during transit/storage. - Failure to control conditions related to the safety of water, cleanliness of food contact surfaces, prevention of cross-contamination, maintenance of hand-washing/toilet facilities, protection of food/packaging, control of employee health, and exclusion of pests.

These failures render the seafood products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm had not submitted a response to the Form FDA 483 issued on November