FDA WARNING_LETTER - Dr Gumbo's New Orleans Cuisine, Inc. - February 07, 2013

On February 5-7, 2013, the FDA inspected Dr. Gumbo’s New Orleans Cuisine, Inc., a seafood processing facility, and found serious violations of seafood HACCP (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110) regulations. The firm's frozen, heat-and-serve seafood entrees are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. Failure to list refrigerated storage as a critical control point for pathogen survival and toxin formation in HACCP plans for multiple seafood products (e.g., Crawfish Julie Sauce, Shrimp and Okra Gumbo), violating 21 CFR 123.6(a) and (c)(2). The firm stated they installed a temperature data logger and included it, but did not provide the revised plan. 2. Lack of HACCP plans to control *Clostridium botulinum* for the same products, violating 21 CFR 123.6(a) and (b). The firm reported including this hazard and using preprinted bags with instructions but failed to provide the revised plan or labeling. 3. Failure to verify the adequacy of the cooking critical limit for pathogen control by not calibrating probe thermometers quarterly at two or more temperature points against a standard reference thermometer