FDA WARNING_LETTER - Phil Jon Farms - September 11, 2012

On September 7 and 11, 2012, the FDA investigated Phil Jon Farms in Greencastle, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that on or about December 22, 2011, Phil Jon Farms sold a dairy cow for slaughter that was adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on December 23, 2011, identified (b)(4) residues in the liver at (b)(4) ppm and in the muscle at (b)(4) ppm, exceeding the FDA tolerances of (b)(4) ppm and (b)(4) ppm respectively, making the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA also found that Phil Jon Farms held animals under insanitary conditions, failing to maintain 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, the firm adulterated the new animal drug (b)(4) by using it in an extralabel manner, specifically administering it to a dairy cow without following the approved route of administration. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. §