FDA WARNING_LETTER - Culinary Crossing Inc. - March 07, 2011

On June 14, 2011, the FDA issued a Warning Letter to Culinary Crossing Inc. following an inspection from February 23 to March 7, 2011, at their Harleysville, PA seafood processing facility. 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 (CGMP) regulation (21 CFR Part 110). As a result, their Seafood Soups were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Inadequate HACCP Plan for *Clostridium botulinum***: The HACCP plan for "Fully cooked, not shelf stable seafood products" lacked a critical control point for *Clostridium botulinum* growth and toxin formation, a likely hazard for products in oxygen-impermeable packaging. The plan referenced a 38°F storage temperature but did not specify secondary barriers like formulation (water activity, pH, salt) or time-temperature integrators. 2. **Missing Critical Limits**: The HACCP plan did not list critical limits for pathogen reduction/survival at the "CCP 1B Internal Temperature of Products Cooked in the Kettle" critical control point, such as cook time, batch size, or portion control. 3