FDA WARNING_LETTER - Superfish S.A.

This FDA Warning Letter, Reference No. 358838, dated July 9, 2012, addresses Superfish S.A. in Poland regarding serious deviations from the Seafood HACCP Regulation (21 CFR Part 123) for their ready-to-eat herring products. The firm's submitted HACCP plans for marinated (pickled) and salted herring products were evaluated and found to render the products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Critical Control Points (CCPs):** HACCP plans lack CCPs for the marinade process to control histamine and pathogen growth, and for finished product storage to control pathogens, including *Clostridium botulinum*. 2. **Inadequate Critical Limits:** Critical limits for scombrotoxin formation (lacking histamine analysis or harvest vessel records), *Staphylococcus aureus* growth in wet batter (inadequate time/temperature), and pathogenic bacteria control during cooking (lacking time limits) were insufficient. Cooling critical limits for scombrotoxin and *C. botulinum* were also inadequate. 3. **Inadequate Monitoring Procedures:** Plans lacked specific details for monitoring raw material organoleptic exams (number of fish, acceptance/rejection criteria, trained personnel), frequency of temperature monitoring throughout processing, and histamine testing protocols. 4. **In