FDA WARNING_LETTER - Mervin Z. Fox Farm - November 05, 2012

On January 9, 2013, the FDA issued a Warning Letter to Mervin Z. Fox Farm following a November 5, 2012, investigation of their dairy operation in Martinsburg, PA. The letter identified multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on May 21, 2012, was found to have penicillin at 0.29 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. §556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. The investigation also revealed insanitary conditions, including a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the new animal drug Penicillin G Procaine Injectable Suspension (NADA 065-010) was adulterated because it was used in an extralabel manner without veterinary supervision, violating 21 C.F.R. §530.11(a) and resulting in an illegal drug residue, violating 21 C.F.R. §530.11(d). This non-conforming use caused