FDA WARNING_LETTER - Krasnyi Oktyabr Inc. - August 07, 2015

On June 15-16, 2015, and again on August 5 and 7, 2015, the FDA inspected Krasnyi Oktyabr USA Inc.'s seafood processing and importer establishment. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).

The FDA determined that the firm's dried salted sprats, dried salted horse mackerel fillets, refrigerated vacuum packaged salted dried bream fish, and refrigerated vacuum packaged salted dried Caspian roach (vobla) were adulterated because they were prepared, packed, or held under insanitary conditions.

Specific violations included: 1. **Inadequate HACCP Plan:** The HACCP plan for refrigerated vacuum packaged salted dried bream fish and Caspian roach listed an inadequate critical limit for controlling *Clostridium botulinum* toxin formation at the receiving critical control point. For transit times exceeding 4 hours, transportation records must show the product was held at or below 40°F throughout transit. 2. **Unavailable Records:** The firm failed to provide receiving records for refrigerated vacuum packaged salted dried bream fish and Caspian roach, and corrective action records for cooler temperatures exceeding critical limits on August 1, 3, and 4, 2015. 3