FDA WARNING_LETTER - Kimriv Restaurant Group, LLC. (DBA) Royal Gourmet Foods - April 20, 2011

On April 13-20, 2011, the FDA inspected Kimriv Restaurant Group, LLC. (DBA) Royal Gourmet Foods, a seafood processing facility in San Diego, CA. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render the firm's fishery products, including pasteurized crab meat, scombroid species, shrimp, and other fish products, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for pasteurized canned crabmeat failed to identify *Clostridium botulinum* growth and toxin formation as a hazard at the "Receiving" critical control point (21 CFR 123.6(a) and (c)(1)). 2. **Missing Critical Control Points:** HACCP plans for scombroid susceptible fish, shrimp, and other seafood did not list "thawing" or "processing" as critical control points to control hazards like pathogen growth, toxin formation (including *Clostridium botulinum* and scombrotoxin), *Listeria monocytogenes*, and parasites (21