FDA WARNING_LETTER - Mkg Provisions Inc - December 28, 2012

On January 30, 2013, the FDA issued a Warning Letter to Mkg Provisions Inc. following an inspection from December 11-28, 2012. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The FDA found that the firm's ready-to-eat fish and fishery products, including cold-smoked vacuum-packed salmon and hot-smoked vacuum-packed marlin, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: * **Lack of HACCP Plan:** The firm did not have a HACCP plan for hot-smoked vacuum-packed marlin to control hazards like pathogenic bacterial growth, *Clostridium botulinum* toxin, allergens/additives, and metal inclusion. * **Inadequate Hazard Analysis:** The HACCP plan for cold-smoked vacuum-packed salmon did not list allergens/additives and metal inclusion as food safety hazards. * **Failure to Implement Monitoring Procedures:** The firm did not continuously monitor "Brining" critical control points for cold-smoked salmon, specifically lacking temperature records for smoking chambers for lots