FDA WARNING_LETTER - Beyer Lightning Fish Co. Inc. - October 04, 2011

On September 21-October 4, 2011, the FDA inspected Beyer Lightning Fish Co. Inc. and found serious violations of seafood HACCP (21 CFR Part 123) and GMP (21 CFR Part 110) regulations. The firm's canned pasteurized crabmeat and vacuum-packed smoked salmon were deemed adulterated due to insanitary conditions.

Key violations include: 1. **Failure to implement monitoring procedures (21 CFR 123.6(b) and (c)(4)):** The firm did not follow its HACCP plan's monitoring procedure for the display area critical control point for smoked vacuum-packed fishery products and canned pasteurized crabmeat to control *Clostridium botulinum*. This was a repeat observation from February and December 2009 inspections. On October 4, 2011, an investigator observed vacuum-packed smoked salmon in a 58°F display area without ice, despite the firm's claim of not displaying such products. 2. **Failure to take appropriate corrective action (21 CFR 123.7(a)):** The firm did not take corrective action for *Clostridium botulinum* control when processes for vacuum-packed smoked salmon and canned pasteurized crabmeat deviated from critical limits at receiving and storage. A cooler temperature chart from November 1-8, 2010,