FDA WARNING_LETTER - Ocean Food Company Limited - October 10, 2011

The FDA issued a Warning Letter to Ocean Food Company Limited following an evaluation of their HACCP plans for pasteurized fish and fishery products, which revealed serious deviations from 21 CFR Part 123, the seafood Hazard Analysis and Critical Control Point regulation. Consequently, the firm's products are deemed adulterated under 21 U.S.C. § 342(a)(4). Key violations include the failure of HACCP plans to list "Undeclared Major Food Allergens" as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). Additionally, the plans lacked critical control points for cooling after pasteurization to control post-process contamination, and for label review to control Clostridium botulinum in reduced oxygen packages (21 CFR 123.6(a) and (c)(2)). The firm's corrective actions were also found inappropriate, failing to ensure adulterated products do not enter commerce (21 CFR 123.7(b)). Further concerns highlighted deficiencies in monitoring methods, specifically regarding the use of End-Point Internal Product Temperature (EPIPT) without scientific validation, and its potential unsuitability for certain Clostridium botulinum spores. The FDA also noted the apparent need for a "Thawing" critical control point and the identification of Staphylococcus aureus growth and toxin formation as a hazard after broiling and frying steps. Ocean Food Company Limited must respond within thirty working days, detailing specific corrective actions, including revised HACCP plans and monitoring records. Failure to adequately address these violations may result in the refusal of admission of their imported products into the U.S., including detention without physical examination.