FDA WARNING_LETTER - Star Food Products, Inc

The FDA inspected Star Food Products Inc., a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the firm failed to implement an affirmative step to ensure imported fish and fishery products, including tuna, were processed in accordance with HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). This renders their Scombrotoxin-forming fish (tuna) adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions.

Additionally, the inspection revealed the firm had not established product specifications or written verification procedures for any imported fish and fishery products. The FDA warned of potential further actions, including refusal of admission, detention without physical examination, seizure, and/or injunction. Star Food Products Inc. was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records, and affirmative step performance. The letter emphasized the firm's responsibility to ensure compliance with the Act and 21 CFR Part 123 to prevent future violations.