Conklin Dairy Sales, LLC – FDA Warning Letter, May 5, 2014

On June 25, 2014, the FDA issued a Warning Letter to Conklin Dairy Sales, LLC, following an investigation conducted on April 15, 17, and May 5, 2014. The investigation revealed several violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on November 20, 2013, was found to have penicillin at 0.301 ppm in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The operation 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 firm engaged in extralabel use of Agri-Cillin (penicillin G procaine) on a dairy cow without following approved labeling for indications, withdrawal period, or dose. This extralabel use was not under the supervision of a licensed veterinarian and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(a) and (d), and rendering the drug unsafe and adulterated under 21 U.S.C. § 360b