FDA WARNING_LETTER - Wild About Food-oklahoma Llc - April 09, 2012

On August 13, 2012, the FDA issued a Warning Letter to Wild About Food-Oklahoma LLC following an inspection from March 28 to April 9, 2012, at their Fort Worth, Texas, seafood processing facility. 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 FDA determined that the firm's clam chowder soup products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. The firm's April 20, 2012, response was deemed insufficient.

Key violations included: 1. **Inadequate HACCP Plan Critical Limits:** * **Hot Fill Packaging CCP #2:** The critical limit of "Product is to be sealed/packaged at a minimum (b)(4) °F" was inadequate because the filling operations were open, allowing recontamination. The firm's proposed corrections did not ensure a totally enclosed system or proper monitoring. * **Finished Product Labeling (Allergen) CCP #6:** The critical limit "Allergen warning label shall be affixed and verified before shipping" was inadequate as it did not ensure specific