FDA WARNING_LETTER - Montana Fish Company - March 11, 2014

On March 4, 5, 7, and 11, 2014, the FDA inspected Montana Fish Company's seafood processing facility at 1401 Gold Avenue, Suite 2B, Bozeman, Montana, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The refrigerated, canned crab products and scombroid species were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

The firm's March 21, 2014, response to the Form FDA 483 was inadequate, lacking documentation to verify corrections. Significant violations included: 1. Failure to conduct a hazard analysis and implement a HACCP plan for refrigerated, canned Super Lump Crabmeat and Claw Crabmeat to control *Clostridium botulinum*, violating 21 CFR 123.6(a) and (b). 2. The HACCP plan for "Scombroid species and related fishes" listed an inadequate critical limit at the "Receive product" CCP, failing to ensure product internal temperature remained at 40 degrees F or below during transit, violating 21 CFR 123.6(c)(3). 3. Failure to take appropriate corrective action for scombrotoxin