Rocky Top Dairy – FDA Warning Letter, Jan 17, 2008
On January 9-17, 2008, an FDA inspection of Rocky Top Dairy in Lovington, New Mexico, revealed that the dairy offered adulterated animals for slaughter and caused new animal drugs to become unsafe and adulterated.
Specifically, a Holstein cow sold on September 18, 2007, for slaughter contained 1.19 ppm Penicillin in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The dairy lacked an adequate system to ensure proper drug withdrawal times, failing to maintain complete treatment records, which adulterated food under 21 U.S.C. § 342(a)(4).
Furthermore, the dairy's extralabel use of [redacted] Injectable Suspension U.S.P. was non-compliant with 21 C.F.R. Part 530. The dairy administered six times the recommended dose without licensed veterinarian supervision, violating 21 C.F.R. § 530.11(a), and this extralabel use resulted in illegal drug residues, violating 21 C.F.R. § 530.11(d). This rendered the drug unsafe under 21 U.S.C. § 360b(a
- Office
- Denver District Office
- Person
ID · e2ef123e-078b-4ccf-ab35-52460c19a4aa
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