FDA WARNING_LETTER - Kato Suisan Co. Ltd. - November 20, 2012

On November 19-20, 2012, the FDA inspected Kato Suisan Co., Ltd. in Japan, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's frozen salted herring roe was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions and under Section 402(a)(2)(C) for containing an unsafe food additive.

The firm's revised HACCP plan for frozen salted herring roe, submitted on December 17, 2012, was inadequate. Key violations included: 1. **Failure to list all reasonably likely food safety hazards (21 CFR 123.6(a) and (c)(1)):** The plan omitted undeclared allergens (fish) and *Clostridium botulinum* growth and toxin formation. The FDA recommended adding "Keep Frozen: Important Keep Frozen and Thaw Under Refrigeration Immediately Before Use" handling instructions and a critical control point (CCP) to monitor their presence. 2. **Failure to list critical limits (21 CFR 123.6(c)(3)):** The plan lacked critical limits for temperature or time at the "(b)(4)" CCP to control pathogen growth. The FDA recommended maintaining temperatures below 4