Bumblefish KC LLC – FDA Warning Letter, Aug 27, 2013

On August 25-27, 2013, the FDA inspected Bumblefish K.C. LLC's seafood processing facility at 4120 Pennsylvania Avenue Suite 10, Kansas City, MO 64111. The inspection revealed serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their ready-to-eat sushi products, including all-natural Salmon Roll, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Significant violations include: 1. Failure to adequately control *Clostridium botulinum* in sushi roll products by not cutting open vacuum-packed fish containers during thawing, violating 21 CFR 123.6(b). 2. Failure to properly calibrate process monitoring equipment (thermometers and pH meter probe), violating 21 CFR 123.8(a)(2)(ii). 3. Failure to maintain sanitation monitoring records, violating 21 CFR 123.11(c). 4. Failure to monitor sanitation conditions and practices with sufficient frequency, with observed instances of employees not wearing hair restraints, unsanitary equipment, and an unsanitary ice machine, violating 21 CFR 123.11(b). 5. Failure to