FDA WARNING_LETTER - Gladys' Seafood, Inc. - April 03, 2015

On April 1-3, 2015, the FDA inspected Gladys' Seafood, Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their pasteurized canned crabmeat adulterated.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan's critical limit for receiving pasteurized canned crabmeat ("Refrigerated temperature less than or equal to (b)(4) F or as marked on product label") is insufficient to control pathogen growth, including *Clostridium botulinum*. This was a repeat observation. The firm also lacked monitoring records for receiving temperatures and the HACCP plan did not reflect actual operations (receiving on ice). 2. **Failure to Implement Monitoring Procedures:** The firm did not continuously monitor cooler temperatures at the Storage critical control point as required by their HACCP plan, specifically for crabmeat stored in a trailer when the main cooler failed in July 2014. Storage monitoring records also lacked actual values, time, and date. 3. **Inappropriate Corrective Actions:** The corrective action plan for the Storage critical control point did not address determining the cause of critical limit deviations, a repeat observation. 4. **Failure to Reevaluate HACCP Plan Annually:** The HACCP plan had not been reevaluated since June 11, 2013