FDA WARNING_LETTER - Osaki Suisan Co., Ltd.

The FDA issued a Warning Letter to Osaki Suisan Co., Ltd. in Osaka, Japan, following an evaluation of their seafood Hazard Analysis and Critical Control Point (HACCP) plan for fish cake. This evaluation was prompted by an importer's request for removal from Import Alert #16-119, which listed Osaki Suisan Co., Ltd.

The FDA found serious deviations from the seafood HACCP regulation (21 CFR Part 123), rendering the firm's fish cake product adulterated under the U.S. Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(1)):** The plan failed to list reasonably likely food safety hazards. * **Clostridium botulinum growth and toxin formation:** Vacuum packaging creates an environment conducive to this hazard, which was not identified. The firm's pasteurization critical limit of "(b)(4)" was inadequate (e.g., no time component, core temperature too low) to achieve a 6D process, and alternative control strategies like immediate freezing with "keep frozen" labeling were not adequately addressed. * **Undeclared allergens:** Finfish, eggs, and wheat (if applicable) were not identified as hazards. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3