FDA WARNING_LETTER - Emrich Farms - February 22, 2013

On February 21 and 22, 2013, the FDA inspected Emrich Farms, a dairy operation in Annville, Pennsylvania, and found violations of the FD&C Act. A dairy cow sold for slaughter on September 18, 2012, was found to have penicillin at (b)(4) ppm in its kidney, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4). Furthermore, the new animal drug (b)(4) was adulterated because it was used extralabelly without veterinary supervision and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(a) and (d). This extralabel use, specifically administering (b)(4) to a dairy cow without following dosage and injection site limitations, caused the drug to be unsafe under section 512(a) and adulterated under section 501(a)(5).

Emrich Farms must take prompt action to correct these violations and prevent recurrence. Failure to comply