FDA WARNING_LETTER - Beck's Smokery - September 30, 2011

On December 7, 2011, the FDA issued a Warning Letter to Beck’s Smokery following an inspection from September 26-30, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The firm's Smoked Fish products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Specific violations include: 1. The HACCP plan for Smoked Fish has an inadequate monitoring procedure at the "Cooled storage/Loading" critical control point to control pathogen growth (21 CFR 123.6(c)(4)). 2. The firm failed to implement the monitoring procedure of checking "temp inside truck" at the Cooled Storage/Loading critical control point for Smoked Fish (21 CFR 123.6(b)). 3. The corrective action plan for Smoked Fish at the "Cooled Storage/Loading" critical control point does not include product evaluation in case of a critical limit deviation (21 CFR 123.7(b)).

The FDA may take further action, including product seizure or injunction, if violations are not corrected. Beck's Smokery