Alliance Dairies – FDA Warning Letter, Mar 12, 2008

On May 28, 2008, the FDA issued a Warning Letter to Alliance Dairies following a March 11-12, 2008 inspection. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold on January 26, 2008, for slaughter was found to have penicillin in kidney tissue at 0.17 ppm, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The dairy also lacked an adequate system to prevent medicated animals with harmful drug residues from entering the food supply, including incomplete treatment records, leading to adulterated food under 21 U.S.C. § 342(a)(4).

Furthermore, Alliance Dairies engaged in extralabel use of penicillin and tylosin without veterinary supervision, violating 21 CFR Part 530. Penicillin was administered without adhering to approved dosage, duration, frequency, and withdrawal periods, resulting in illegal residues (21 CFR 530.11(d)). Tylosin, not approved for lactating dairy cattle, was also used improperly. These actions caused the drugs to be unsafe (21 U.S.C. § 360b(a)) and adulterated (21