FDA WARNING_LETTER - Peter & Dawn Erlwein - January 16, 2015

On January 5, 14, and 16, 2015, the FDA inspected Peter and Dawn Erlwein's cattle operation in Jeffersonville, New York. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, a bob veal calf sold for slaughter around (b)(4) was found to have ciprofloxacin residue in its kidney tissue, for which no tolerance has been established in veal. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also held animals under insanitary conditions, failing to maintain complete treatment records and identify animals transported for sale, leading to potential harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug (b)(4) (enrofloxacin) was adulterated. The drug was used extralabelly on a bob veal calf without following approved labeling or veterinary prescription, and not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This extralabel use resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c), and was a prohibited use of a fluoroquinolone in an unapproved production