FDA WARNING_LETTER - DG Farms - September 24, 2014

On September 17, 19, and 24, 2014, the FDA inspected DG Farms in Pixley, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated heifer for slaughter on February 27, 2014. USDA/FSIS analysis of the animal's kidney tissue revealed 0.91 ppm of desfuroylceftiofur, exceeding the FDA tolerance of 0.4 ppm, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, DG Farms was cited for holding animals under insanitary conditions, specifically failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). The letter also identified adulteration of new animal drugs: ceftiofur sodium, flunixin meglumine, and penicillin G procaine. DG Farms used these drugs in an extralabel manner without following approved labeling or their servicing veterinarian's prescription regarding indications for use, route of administration, and dosage per injection site, respectively. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and causing the drugs to be unsafe and adulterated under