FDA WARNING_LETTER - Rahm Dairy LLC

On July 16, 2015, an FDA investigation of Rahm Dairy LLC in Colby, Wisconsin, revealed violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on March 2, 2015. USDA/FSIS analysis of kidney tissue from this animal showed desfuroylceftiofur (ceftiofur marker residue) at 5.98 ppm, exceeding the FDA tolerance of 0.4 ppm (21 CFR 556.430). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that Rahm Dairy LLC held 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. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug ceftiofur hydrochloride (NADA (b)(4)) was adulterated due to extralabel use. The drug was administered to a dairy cow without following the approved dosage per injection site. This extralabel use was not under the supervision of a licensed veterinarian (violating 21 CFR 530.11(a)) and resulted in an illegal drug residue (violating 2