FDA WARNING_LETTER - The Cherry Co., Ltd. - July 21, 2011

The FDA issued a Warning Letter to The Cherry Co., Ltd. following an inspection of their seafood importer establishment in Honolulu, Hawaii, from July 12-21, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, specifically 21 CFR Part 123 and 21 CFR 123.12, concerning imported fish and fishery products. As a result, their imported dried shaved mackerel & scad, and dried shaved bonito from Japan were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The primary deficiencies identified were the firm's failure to have product specifications designed to ensure imported fish and fishery products are not injurious to health, as required by 21 CFR 123.12(a)(2)(i). These specifications were lacking for hazards such as histamine, pathogen growth, toxin formation, undeclared allergens/additives, and metal inclusion. Additionally, the firm failed to implement an affirmative step to ensure imported products were processed according to FDA's seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii). Although the firm provided a HACCP plan in response to the FDA-483, it was deemed insufficient as it did not address all associated hazards and controls. The FDA requires a written response within 15 working days, outlining specific corrective actions and supporting documentation, warning of potential actions including refusal of admission, detention, seizure, or injunction if violations are not corrected.