FDA WARNING_LETTER - Sanitary Dairy Foods Inc. - August 29, 2013

On August 27-29, 2013, the FDA inspected Sanitary Dairy Foods, Inc., a cheese manufacturer in Saint Louis, MO. The inspection revealed significant deviations from Current Good Manufacturing Practice regulations (21 CFR Part 110), rendering the firm's cheese products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Violations included: 1. Failure to minimize potential for microbial growth or food contamination (21 CFR 110.80(b)(2)). Environmental samples showed generic, non-toxigenic *Escherichia coli* (*E. coli*) in eleven processing locations, including the mixing and packaging rooms. Additionally, a finished baker's cheese product sample collected on July 23, 2013, tested positive for *E. coli* at >1,100 MPN/gram, indicating insanitary conditions. 2. Failure to protect food contact surfaces from contamination (21 CFR 110.10(b)(9)). An employee packaging baker's cheese inserted a gloved hand/arm into plastic product bags, then operated equipment and performed other duties without washing/sanitizing hands or changing gloves before touching the inside of subsequent bags.

The FDA requires immediate corrective actions within fifteen working days, including steps taken to correct violations and prevent recurrence, with