Pleasant View Farms, Inc. – FDA Warning Letter, Feb 29, 2012
On December 15 and 20, 2011, and February 29, 2012, the FDA investigated Metzler & Sons, LLC's dairy operation. The investigation found that the company offered for sale an animal for slaughter as food that was adulterated. Specifically, a bob veal calf sold on September 19, 2011, contained 0.14 ppm of penicillin residue in kidney tissue, exceeding the FDA tolerance of 0.05 ppm. This violates section 402(a)(2)(C)(ii) of the FD&C Act, deeming the food adulterated due to unsafe new animal drug residue.
The FDA also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, a violation of section 402(a)(4) of the FD&C Act. An example cited was the failure to maintain treatment records.
Furthermore, the company adulterated the new animal drug penicillin G procaine (Durvet, Penicillin G Procaine Injectable Suspension, NADA #065-505) by using it extralabelly without following approved labeling dosage and without the supervision of a licensed veterinarian. This extralabel use resulted in an illegal drug residue, violating 21 C.F.R. 530.11(a) and (d), and rendering
ID · 4e8cd889-41ae-4003-a273-4df6d7b37f2f
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.