FDA WARNING_LETTER - American Yeast Corp. Tennessee - January 20, 2012

On January 9-12, 18, and 20, 2012, the FDA inspected American Yeast Corporation Tennessee's fresh baker’s yeast manufacturing plant in Memphis, TN, finding numerous insanitary conditions. These conditions render their food products adulterated under Section 402(a)(4) of the Food, Drug, and Cosmetic Act [21 USC 342 (a)(4)].

Key violations include: 1. **Facility Design and Maintenance (21 CFR 110.20(b)(4), 21 CFR 110.35(a)):** The mezzanine production area had standing water, brown fluid dripping onto the floor, and in-process yeast on the floor. The mezzanine design allowed liquid to drip onto manufacturing equipment below. A fine liquid mist was observed near the five-pound production line. Holes and missing flooring, filled with standing water, were present in the packaging room. The company's response, mentioning an engineering study and floor patching by March 31, 2012, was deemed inadequate due to lack of detail and immediate actions. 2. **Hygienic Practices (21 CFR 110.10(b), 21 CFR 110.10(b)(5)):** An employee on the five-pound packaging line picked up crumbled yeast from the floor and adjusted a