FDA WARNING_LETTER - Sterling Heights Dairy Farm LLC - June 02, 2014

On May 1, 22, and June 2, 2014, the FDA inspected Sterling Heights Dairy Farm, LLC, finding multiple violations. A dairy cow sold for slaughter on January 20, 2014, was found to have 1.91 ppm of desfuroylceftiofur in its kidney, exceeding the 0.4 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The farm also failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, violating 21 U.S.C. § 342(a)(4). Furthermore, the new animal drug Excenel RTU EZ (ceftiofur hydrochloride) was adulterated. The farm administered Excenel RTU EZ to a dairy cow (farm tag 2501) without adhering to the approved withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(d). This rendered the drug unsafe under 21 U.S.C. § 360b(a)