FDA WARNING_LETTER - Rocky Top Dairy - January 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