FDA WARNING_LETTER - Johnson Farm LLC - August 05, 2013

On July 30 and August 5, 2013, the FDA inspected Johnson Farm LLC's dairy operation in New Berlin, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 28, 2013, Johnson Farm LLC sold a culled dairy cow for slaughter. USDA/FSIS analysis of the animal's kidney tissue found desfuroylceftiofur (a marker for ceftiofur) at 7.55 ppm, exceeding the FDA tolerance of 0.4 ppm. This rendered the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found that the farm held animals under insanitary conditions, failing to maintain adequate treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the new animal drug (Ceftiofur Crystalline Free Acid) was adulterated because it was used extralabelly without following approved labeling or a veterinarian's prescription. The farm administered the drug without observing the withdrawal period and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and resulting in an illegal drug residue, violating 21 C