FDA WARNING_LETTER - Mackinac Straits Fish Company, inc. - June 13, 2008

On October 8, 2008, the FDA issued a Warning Letter to Mackinac Straits Fish Company, Inc., following an inspection from June 11-13, 2008. 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 vacuum-packed smoked whitefish sausage and smoked freshwater fish fillet products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plan Monitoring:** The HACCP plan for vacuum-packaged Smoked Whitefish Sausage lacked adequate monitoring procedures/frequencies at the Cool and Store critical control points to control pathogen growth and *Clostridium botulinum* toxin formation, as they were not designed to measure critical limits (21 CFR 123.6(c)(4)). 2. **Failure to Take Immediate Corrective Actions:** The firm did not take immediate corrective actions when deviations from target water phase salt levels were found during verification testing of refrigerated vacuum-packaged Smoked Whitefish Sausage. Corrective actions taken were inadequate, failing to segregate affected products, determine acceptability for distribution, or ensure no injurious product entered commerce (21 CFR 123.