FDA WARNING_LETTER - Earl Wolfe Farms Inc - August 08, 2013

On July 26, August 2, and 8, 2013, the FDA investigated Earl Wolfe Farms, Inc. and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on October 16, 2012. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 17, 2012, revealed 2.864 ppm of penicillin in the kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. § 556.510). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

Additionally, the investigation found that the farm held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Specific deficiencies included failure to maintain treatment records, an inadequate drug inventory system, and not adhering to drug residue withdrawal hold times. These conditions render food adulterated under section 402(a)(4) of the Act.

Earl Wolfe Farms, Inc. is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective steps, including documentation, must be submitted to the FDA within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions such as seizure and