FDA WARNING_LETTER - Tony Crab King, Inc. - July 06, 2010

On November 8, 2010, the FDA issued a Warning Letter to Tony Crab King, Inc. following an inspection from June 23 to July 6, 2010. 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). These violations render the firm's refrigerated ready-to-eat (RTE) canned crabmeat, cooked seasoned crab claws, and oysters adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for RTE cooked seasoned crab claws to control pathogen growth during receiving, storage, and display. 2. **Missing Critical Limits:** The HACCP plan for "Pasteurized Crab Meat" lacks critical limits for the "Receiving" Critical Control Point (CCP) to control pathogen growth, including *Clostridium botulinum*. 3. **Inadequate Monitoring and Record Keeping:** The firm failed to follow monitoring procedures and frequencies for canned pasteurized crab meat at the display CCP, using inadequate cooling media. Additionally, monitoring observations at the receiving CCP were not recorded, with no records of canned pasteurized crab meat temperature upon receipt. 4. **Insufficient