FDA WARNING_LETTER - Royal Seafood Baza - March 19, 2015

On March 12-19, 2015, the FDA inspected Royal Seafood Baza, Inc., a seafood processing and importing facility, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulation (21 CFR Part 110). The inspection resulted in an FDA-483, and despite the firm's April 18, 2015 response, significant violations persist.

The FDA determined that the firm's salt-cured herring fillets and caviar products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Key violations include:

1. **Inadequate Hazard Analysis:** The HACCP plan for "Caviar Products" failed to list *Clostridium botulinum* growth and toxin formation as a hazard at the "Labeling of Finished Product" critical control point, especially given labels allowing two weeks of refrigerated storage. 2. **Missing Critical Control Points (CCPs):** The caviar HACCP plan omitted refrigerated storage and unrefrigerated processing controls for pathogen growth and toxin formation. 3. **Insufficient Critical Limits:** HACCP plans for salt-cured herring fillets lacked adequate critical limits for scombrotoxin (histamine) formation during thawing