Brede, Inc. – FDA Warning Letter, Jun 18, 2008

On August 21, 2008, the FDA issued a Warning Letter to Brede, Inc. following an inspection of their horseradish and horseradish-based manufacturing facility in Detroit, Michigan, from June 3-18, 2008. The inspection revealed significant deviations from current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110), causing the manufactured foods to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Violations included: 1. **Equipment Maintenance (21 CFR § 110.40(a), (c), (d)):** An employee used an unwashed plastic pipe retrieved from the floor to dispense prepared horseradish. 2. **Sanitation and Pest Control (21 CFR § 110.10(b)(8), § 110.80(b)(7), § 110.35(c)):** An employee was observed smoking near food packaging containers. Containers were not protected from contamination. Pests, including winged and flying insects, were observed on food-contact surfaces and in the processing area, with an open bay door contributing to pest entry. 3. **Facility and Equipment Cleanliness (21 CFR § 110.35(a), § 110.40(a), (b)):** Significant