FDA WARNING_LETTER - Fukusui Shoji Ltd. - February 09, 2023

The FDA issued a warning letter to Fukusui Shoji Ltd., a seafood processing facility located in Fukuoka, Japan, following an inspection conducted on February 8-9, 2023. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations under Title 21, Code of Federal Regulations, Part 123. The primary issues identified include the failure to conduct a proper hazard analysis for their "Fresh Fish Group C" products, particularly the omission of Clostridium botulinum as a potential hazard. Additionally, the company"s HACCP plan lacks adequate critical limits and monitoring procedures to control scombrotoxin (histamine) formation.

The regulatory framework cited includes the Federal Food, Drug, and Cosmetic Act, under which the company"s products are deemed adulterated due to these violations. The FDA requires Fukusui Shoji Ltd. to submit a written response within 15 working days, detailing corrective actions taken to address these deviations. This response should include a revised HACCP plan, documentation of implemented changes, and evidence of compliance through monitoring records. Failure to adequately address these issues may result in further regulatory actions, such as the refusal of admission of imported products into the U.S. and potential detention without physical examination.

The company is urged to ensure compliance with all applicable regulations, including the seafood HACCP and Current Good Manufacturing Practice regulations, to prevent future violations. Correspondence should be directed to Sheena Phillips, Compliance Officer at the FDA.