FDA WARNING_LETTER - Inland Meats, Inc. - July 22, 2010

On July 21-22, 2010, the FDA inspected Inland Meats, Inc.'s food processing facility in Spokane, Washington, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110). These violations render their refrigerated salmon products in impermeable vacuum packaging 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 include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Fresh Seafood - Vacuum Packing in Plastic" fails to list a critical control point for controlling *Clostridium botulinum* growth and toxin formation during distribution. The revised plan's critical control point of "Halibut, Salmon" refers to products, not appropriate processing steps. The packaging's oxygen transmission rate is insufficient to prevent *Clostridium botulinum* growth. 2. **Missing Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan lacks a critical limit at the "Halibut Salmon" critical control point to control *Clostridium botulinum* growth and toxin production