FDA WARNING_LETTER - Wild Foods, Inc - April 26, 2011

The FDA inspected Wild Foods, Inc. dba Ma Baensch’s, Baensch Food Products Co. at 1025 E. Locust Street, Milwaukee, Wisconsin, from February 15 to April 26, 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).

Specifically, the firm's Marinated Herring with Sour Cream & Chives and Marinated Herring in Wine Sauce products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under insanitary conditions. The primary violation is the firm's failure to have and implement a written HACCP plan for these products to control food safety hazards, including pathogens like Clostridium botulinum and histamine, as required by 21 CFR 123.6(a) and (b).

The FDA may take further action, including product seizure and/or injunction against the firm's operation, if these violations are not promptly corrected. Wild Foods, Inc. must respond in writing within 15 working days, outlining specific corrective actions, including HACCP and verification records. If