# FDA WARNING_LETTER - Empire Dairy - January 14, 2010

Source: https://www.keypedia.com/records/warning_letter/empire-dairy/c55ac4b6-fe70-41ef-858a-b0e188f9cb97

> FDA WARNING_LETTER for Empire Dairy on January 14, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Empire Dairy
- Inspection Date: 2010-01-14
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On March 17, 2010, the FDA issued a Warning Letter to Empire Dairy, LLC, following an investigation from January 8-14, 2010, at their Wiggins, CO, facility. The investigation found that Empire Dairy offered for sale adulterated animals for slaughter.

Specifically, a dairy cow sold around (b)(4) with tag (b)(4) was found to have 12.2 ppm of Desfuroylceftiofur in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. § 556.113). Another dairy cow, tag (b)(4), sold around (b)(4), had 1.524 ppm Flunixin in liver tissue (tolerance 0.125 ppm) and 0.0558 ppm Flunixin in muscle tissue (tolerance 0.025 ppm) (21 C.F.R. § 556.286). These levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].

The FDA also cited Empire Dairy for holding animals under insanitary conditions, leading to potential drug residues in the food supply, violating section 402

## Related Officers

- [H.](https://www.keypedia.com/people/thomas-warwick/62a2152a-d2c5-4362-bd12-f90807ff0b26)

Company: https://www.keypedia.com/companies/empire-dairy/ab5b04d3-4a6e-40f0-b334-c126c86ded5d

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861