FDA WARNING_LETTER - wild foods, inc. - April 26, 2011

The FDA inspected Wild Foods, Inc. dba Ma Baensch's seafood processing facility in 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 were 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 cited was the firm's failure to conduct a hazard analysis 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 warned that failure to promptly correct these violations could lead to further action, such as product seizure or injunctions preventing the firm from operating. Wild Foods, Inc. was required to respond in writing within 15 working days, outlining specific corrective actions, including documentation like HACCP and verification records. The letter also stated that the listed