FDA WARNING_LETTER - Capt'n Chuncky's Crab Cake Company, LLC - February 10, 2011

The FDA inspected Capt'n Chucky's Crab Cake Company, LLC from January 31 to February 10, 2011, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110). Consequently, several of the firm's seafood products are deemed adulterated under the Federal Food, Drug, and Cosmetic Act. Additionally, the "Crab Critters" Appetizer product is both adulterated and misbranded due to multiple labeling deficiencies. HACCP violations include the absence of HACCP plans for certain products to control hazards like pathogen growth, toxin formation, undeclared sulfites, and allergens. The firm failed to implement required record-keeping for critical control points and did not adequately monitor sanitation conditions, such as preventing cross-contamination and maintaining food contact surface cleanliness. Sanitation control records were also not maintained. Further HACCP plan deficiencies involved not listing Staphylococcus aureus as a hazard for a specific product, and inadequate monitoring procedures and critical limits across various products and critical control points (e.g., receiving, storing, defrosting, freezing, cooking). Corrective action plans were also found to be insufficient. Labeling violations for "Crab Critters" Appetizers include the failure to declare major food allergens, list common or usual names of all ingredients (including sub-ingredients), provide adequate net quantity of contents, include nutrition information, state the presence of artificial flavors, and disclose the color additive carmine. The FDA requires prompt corrective action within 15 working days, including documentation, to prevent further enforcement actions like seizure or injunction.