FDA WARNING_LETTER - Eastern Treats Specialty Foods, Inc. - September 15, 2011

On October 6, 2011, the FDA issued a Warning Letter to Eastern Treats Specialty Foods, Inc. following an inspection from September 13-15, 2011. 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 regulation (21 CFR Part 110).

The firm's crab cakes were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Specific violations included:

1. **Failure to Implement Monitoring Procedures (21 CFR 123.6(b) and (c)(4)):** * The firm did not monitor product temperature for each delivery at the receiving critical control point for *Clostridium botulinum* as specified in their HACCP plan for "Crab Cake – Can Pasteurized Natural." * The firm failed to monitor and document the calibrated digital continuous thermometer daily at the storage critical control point for *Clostridium botulinum*, specifically from July 1-6, 2011, and August 3-12, 2011.

2. **Failure to Implement Record Keeping System (21 CFR 123.6(b) and (c)(7)):**