FDA WARNING_LETTER - Burr Favara - December 19, 2012

On December 17-19, 2012, the FDA inspected Burr Favara Enterprises' seafood processing facility in Omaha, NE, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). These violations render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, the firm failed to have a written HACCP plan for ready-to-eat tuna products, including Tuna Salad Sandwiches, as required by 21 CFR 123.6(a) and (b). Additionally, a cGMP violation was observed where an employee handled a walk-in freezer door and a trash can, then returned to making ready-to-eat products without washing or sanitizing hands, violating 21 CFR 110.10(b)(3).

The FDA acknowledged the firm's January 2, 2013, response to the FDA-483 but found it inadequate due to a lack of detail regarding proposed corrective actions. The FDA stated it would verify corrective actions during the next inspection and warned of potential further actions, including product seizure or injunction, if violations are not promptly corrected. The firm was required to respond in writing