FDA WARNING_LETTER - West Hope Dairy, LLC

On February 3, 2015, the FDA issued a Warning Letter to West Hope Dairy, LLC, following a December 2, 2014, investigation. The letter details violations of the Federal Food, Drug, and Cosmetic Act related to an adulterated dairy cow sold for slaughter and improper drug use.

Specifically, on March 5, 2014, a dairy cow sold by West Hope Dairy was found to have 9.04 ppm of desfuroylceftiofur (ceftiofur marker residue) in its kidney tissue, exceeding the FDA tolerance of 0.4 ppm. This renders the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records and a drug inventory system, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, the drug (b)(4) (ceftiofur crystalline free acid) was used extralabelly without veterinary supervision and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(a) and (d). This rendered the drug unsafe and adulterated under 21 U.S.