# FDA WARNING_LETTER - Bluegrass Proteins, Inc. - June 12, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/bluegrass-proteins-inc/a1d831a2-6f2c-4569-a6cd-2504c765d162

> FDA WARNING_LETTER for Bluegrass Proteins, Inc. on June 12, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bluegrass Proteins, Inc.
- Inspection Date: 2017-06-12
- Product Type: Food
- Office Name: Minneapolis District Office
- Summary: 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

## Related Officers

- [Acting Assistant Commissioner](https://www.globalkeysolutions.net/people/michael-dutcher/5e9981f8-673f-4a2c-a0b5-dd5e8e8de1f4)
- [David A. Cornelius](https://www.globalkeysolutions.net/people/david-a-cornelius/081d4d6a-bd66-4428-bc83-17f8511c756a)

Company: https://www.globalkeysolutions.net/companies/bluegrass-proteins-inc/d5d95ce7-ab94-4920-98ad-dacfc82b460c

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d