FDA WARNING_LETTER - My Lady's Manor Farm, Inc. - October 16, 2014

On October 14 and 16, 2014, the FDA inspected My Lady's Manor Farm, Inc., a dairy operation. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on June 23, 2014, the farm sold a culled dairy cow for slaughter that contained 10.0 ppm of neomycin residue in the kidney, exceeding the FDA tolerance of 7.2 ppm (21 C.F.R. 556.430). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the farm failed to maintain treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, adulterating food under section 402(a)(4) of the FD&C Act.

The farm also illegally used the new animal drug Neosol Oral (neomycin sulfate antibacterial, ANADA #200-289) in an extralabel manner. The drug was administered to the culled dairy cow without following the recommended dose and for a class of animal (female dairy cattle 20 months or older) not specified in the approved labeling. This extralabel use was not under the supervision of a licensed veterinarian and resulted in illegal residues, violating 21 C.F.R.