FDA WARNING_LETTER - Carry All Provisions Inc - July 19, 2013

On August 8, 2013, the FDA issued a Warning Letter to Carry All Provisions, Inc. following an inspection from July 16-19, 2013, which 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 ready-to-eat (RTE) refrigerated canned pasteurized crabmeat and RTE refrigerated seafood salads were deemed adulterated due to insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm failed to have a written HACCP plan for RTE refrigerated canned pasteurized crabmeat and RTE refrigerated seafood salads to control pathogen growth and toxin formation, specifically *Clostridium botulinum*, as required by 21 CFR 123.6(a) and (b). The FDA recommended assessing time/temperature abuse during receipt and storage. 2. **No Sanitation Control Records:** The firm did not maintain sanitation monitoring records for conditions such as water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, protection from contaminants, toxic compound control, employee health, and pest exclusion, violating 21 CFR 123.11(c). 3. **Inadequate Refrigeration:** A walk-in cooler containing seafood products was observed at (b)(