E. W. Mailhot Sausage Company – FDA Warning Letter, Feb 11, 2014

On March 17, 2014, the FDA issued a Warning Letter to E. W. Mailhot Sausage Company following an inspection of their seafood processing facility in Lewiston, ME, on January 30, February 7, and 11, 2014. 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 for foods (21 CFR Part 110).

The cooked, ready-to-eat salmon pies produced by the firm were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to preparation, packing, or holding under insanitary conditions.

Specific violations included: 1. **Inadequate Critical Limit:** The HACCP plan for salmon pies listed an internal temperature critical limit for cooking that was not scientifically validated and insufficient to control pathogenic bacteria survival (21 CFR 123.6(c)(3)). 2. **Missing Critical Control Point:** The HACCP plan failed to list in-process refrigerated cooler storage as a critical control point to control pathogenic bacteria growth and toxin formation from time and temperature abuse (21 CFR 123.6(a) and (c)(2)). Although cooler storage was listed, its critical limit stated it did "not apply to the pie