FDA WARNING_LETTER - Cracovia Co - June 24, 2011

On June 15-24, 2011, the FDA inspected Cracovia Co.'s seafood processing facility in Linden, NJ, finding serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. Consequently, Cracovia Co.'s refrigerated seafood products, including vacuum-packed smoked mackerel, herring fillets in wine marinade, and smoked salmon, were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Failure to implement monitoring procedures:** The firm did not check temperatures of incoming shipments or refrigerated storage units as specified in their HACCP plans, with numerous instances of missing temperature records. 2. **Inadequate HACCP plan monitoring procedures:** The receiving CCP monitoring for seafood in wine marinade was insufficient for controlling *Clostridium botulinum*, as a one-time temperature check is inadequate for long transit times. The refrigerated storage CCP monitoring was also inadequate, recommending continuous monitoring devices. 3. **Failure to list all hazards in HACCP plan:** The HACCP plan for seafood products in wine marinade did not list Scombrotoxin (histamine) formation as a reasonably likely food safety hazard. 4. **Inadequate critical limits:** Critical limits for receiving and refrigerated storage of vacuum-packed smoked seafood products allowed temperatures above 4