FDA WARNING_LETTER - MC Fish Co - March 23, 2018

On March 20-23, 2018, the FDA inspected MC Fish Company's seafood processing facility in Milton, Kentucky, and found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's paddlefish meat and roe adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** HACCP plans for paddlefish meat and roe failed to list allergens (fin-fish) as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). 2. **Insufficient Critical Limits:** The paddlefish roe HACCP plan's "SALT/ROE RATIO (concentrations)" critical limit at the Salting CCP was inadequate to control *Clostridium botulinum*. It lacked specific minimum/maximum values to ensure a 5% water phase salt in the finished product (21 CFR 123.6(c)(3)). 3. **Failure to Implement Monitoring and Verification Procedures:** * **Refrigeration CCP (*Clostridium botulinum*):** The firm failed to conduct daily visual temperature checks for the packaged roe refrigerator, despite implementing a continuous chart recorder in January 2016.