FDA 483 - Thumb Oilseed Producers' Cooperative - February 23, 2010

This FDA Form 483 details observations from an inspection of a facility producing Non-GMO soy flour, Non-GMO soy grits, Organic soy flour, Organic soy grits, and animal feed.

The facility released finished Non-GMO soy flour lots positive for Salmonella sp. on two occasions. Lot TF121608, positive on 12/22/08, was retested on 01/17/09 and subsequently released into commerce in four deliveries between 01/13/09 and 03/27/09. Lot TF092409, positive on 10/20/09, was released into commerce as animal feed on 10/19/09.

Manufacturing practices were observed that could lead to contamination. Raw soybeans are processed through extruders for approximately ten minutes before reaching the target temperature of 180°F, potentially contaminating the system. No cleaning or sanitizing occurs before processing soybeans into soy grits and flour once the extruder reaches temperature.

Bulk transfer totes, used up to 15 times for finished product, are stored in cardboard boxes near an overhead door, potentially exposing them to contamination. Totes are not sanitized between uses.

Cleaning and sanitizing operations for food-contact surfaces are inadequate; no sanitizer is used. Employees were observed cleaning expellers by flushing with raw soybeans and cleaning pulverizers by banging them with