FDA WARNING_LETTER - Chesapeake Crab Connection Co - December 21, 2010

On April 6, 2011, the FDA issued a Warning Letter to Chesapeake Crab Connection Co. following an inspection from December 16-21, 2010. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The firm's Vacuum Packaged Frozen Crab Cakes and Ready-To-Eat Steamed Crabs were deemed adulterated due to insanitary conditions. Specific HACCP violations included the absence of HACCP plans for these products to control pathogen growth and toxin formation, failure to monitor sanitation conditions (e.g., lack of backflow prevention, employees without hair restraints), and failure to maintain sanitation monitoring records for various critical areas.

Additionally, Vacuum Packaged Frozen Crab Cakes were misbranded under multiple sections of the Act (403(e), 403(i), 403(q), 403(w)) because they lacked allergen declarations (crustacean shellfish, soy, egg, wheat, milk), a statement of identity, an ingredient list (including sub-ingredients for multi-component items like mayonnaise and bread crumbs), the manufacturer's name and place of business, net quantity of contents, and nutrition information.

Furthermore, the facility was not registered with the FDA as required by Section 415 of