FDA WARNING_LETTER - Thumb Oilseed Producers' Cooperative - February 23, 2010

The FDA conducted an inspection of Thumb Oilseed Producers' Cooperative's soy grit and soy flour manufacturing facility in Ubly, MI, from January 28 to February 23, 2010. Environmental samples revealed *Salmonella senftenberg* (S. senftenberg) with an indistinguishable PFGE pattern in 43 areas, indicating an established niche environment. A finished product sample of "Organic Low - Fat Soy Flour" (FDA sample 519231) also tested positive for S. senftenberg, with an indistinguishable PFGE pattern to environmental isolates from non-food contact surfaces (forklift wheel, processing floor gap).

These findings led to the determination that the firm's products were adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (prepared, packed, or held under insanitary conditions) and Section 402(a)(1) (bearing or containing a poisonous or deleterious substance). The firm initiated a voluntary recall on February 25, 2010.

The FDA noted serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), including potential cross-contamination routes, documented in Form FDA-483. The firm's responses from March and April 2010 were deemed inadequate, lacking details on the decontamination plan (methods, sanitizing agents), ongoing environmental