Bluegrass Proteins, Inc. – FDA Warning Letter, Jun 12, 2017

The FDA issued a Warning Letter to Bluegrass Dairy and Foods, Inc. following a May 22 to June 12, 2017, inspection of their Dawson, Minnesota, milk-based powder manufacturing facility. The inspection revealed the presence of *Salmonella* in environmental samples from processing areas, including *Salmonella Tennessee* and *Salmonella Johannesburg*. This was not the first instance, as *Salmonella* was also found in 2014 and 2016 inspections, and the firm's internal monitoring showed a high positive rate.

The FDA cited several Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), rendering products adulterated under 21 U.S.C. § 342(a)(4). Violations included: 1. **Facility Construction:** Water leaks and condensation in multiple areas, including vacated aseptic production, dust collection, and external air filter units, posing a contamination risk, especially for low-moisture foods. 2. **Production Procedures:** Inadequate cleaning and sanitation SOPs lacking detail on sanitizer preparation, concentration verification, and application time/temperature. Water was observed in the spray dryer department. 3. **Temperature Control:** The North Cooler, storing cheese and enzyme-modified cream, consistently exceeded 45°F, leading to molding and potential growth of undesirable microorganisms. 4. **Pest Control:** Apparent beetle-like