Empire Dairy – FDA Warning Letter, Jan 14, 2010
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
ID · c55ac4b6-fe70-41ef-858a-b0e188f9cb97
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