FDA WARNING_LETTER - Faihopity Farms, LP

On July 31, 2014, the FDA issued a Warning Letter to Faihopity Farms, LP, following a June 3, 2014, investigation of their dairy farm in Berwick, Pennsylvania. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on February 17, 2014, Faihopity Farms sold a bob veal calf for slaughter, which, upon USDA/FSIS analysis on February 20, 2014, was found to have sulfadimethoxine in its kidney. This drug residue exceeded the established tolerance of 0.1 ppm for cattle and, critically, has no acceptable level in pre-ruminating veal calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA also found that the farm held animals under insanitary conditions, specifically failing 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) of the FD&C Act.

Furthermore, Faihopity Farms adulterated the new animal drug Albon (sulfadimethoxine) (NADA 31-715) by using it extralabelly without following approved labeling for the animal class and without