FDA WARNING_LETTER - TSUKIJI MOTOHIKO CO., LTD. - February 22, 2019

On May 7, 2019, the FDA issued a Warning Letter to Tsukiji Motohiko Co., Ltd. following an inspection of their seafood processing facility in Tokyo, Japan, on February 21 & 22, 2019. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123).

The primary violation cited was the firm's failure to have a written HACCP plan for frozen, vacuum-packaged salmon wrapped seaweed, herring wrapped seaweed, and threaded herring products. This omission meant the firm lacked controls for reasonably likely food safety hazards, specifically undeclared allergens and Clostridium botulinum growth and toxin formation. The FDA noted that the HACCP plan should include handling instructions like "Keep Frozen, Thaw under refrigeration immediately before use" and ensure accurate allergen labeling (e.g., soy).

The FDA deemed the firm's responses from March 7 and April 1, 2019, inadequate as they did not include a HACCP plan. Consequently, the firm's products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Tsukiji Motohiko Co., Ltd. was required to respond in writing within fifteen working days, outlining specific corrective actions, including a revised HACCP plan and five consecutive days of completed monitoring records to demonstrate