FDA WARNING_LETTER - Octopus Garden, Inc. - November 23, 2011

The FDA inspected Octopus Garden, Inc. in Brooklyn, NY, on multiple dates in November 2011, identifying a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. The firm failed to have and implement a written HACCP plan for its refrigerated pre-packaged Ready-to-Eat White Anchovy Fillets marinated in vegetable oil. This plan is required to control food safety hazards such as pathogen growth and potential toxin formation, including Clostridium botulinum and histamine, as mandated by 21 CFR 123.6(a) and (b). Consequently, these anchovy fillets are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA warns that further action may be taken, including refusal of admission for imported products, seizure, or injunction. Octopus Garden, Inc. must respond in writing within fifteen working days, detailing specific corrective actions, including HACCP and importer verification records. The letter also reminds the firm of its responsibility to comply with 21 CFR Part 123 and Part 110 (Current Good Manufacturing Practice) and notes that re-inspection fees may be assessed.