FDA WARNING_LETTER - Michigan Brands, Inc. - July 01, 2014

The FDA inspected Michigan Brands, Inc., a smoked seafood processing facility, from June 17 to July 1, 2014, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The inspection resulted in an FDA-483, and the firm's July 16, 2014, response was deemed inadequate due to a lack of updated HACCP plan documentation.

The FDA determined that Smoked Alligator, Salmon Smoked Strips, and Salmon Smoked Fillet products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Significant violations include:

1. **Lack of Hazard Analysis and HACCP Plan:** The firm failed to conduct a hazard analysis and implement a HACCP plan for Smoked Alligator and Salmon Smoked Strips to control *Clostridium botulinum*, pathogenic bacteria growth, toxin formation, and allergens. The existing HACCP plan for Salmon Fillet was deemed insufficient to cover these different products. (21 CFR 123.6(a) and (b)) 2. **Inadequate Critical Control Points (CCPs):** The HACCP plan for vacuum-packaged, hot smoked salmon fillets did not list drying as a CCP to control *Clostridium botulinum* formation, nor did it include finished product labeling as a