Providence Dairy – FDA Warning Letter, Feb 13, 2015

On February 10, 11, and 13, 2015, the FDA inspected Providence Dairy in Texico, New Mexico, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved selling an adulterated dairy cow for slaughter on December 11, 2014. USDA/FSIS analysis of tissue samples from this animal, slaughtered on December 12, 2014, revealed 1.51 ppm of desfuroylceftiofur in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 CFR 556.113(b)(3)(i)). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, specifically a failure to maintain complete treatment records and verify withdrawal times, leading to the likelihood of 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 new animal drug (b)(4) (NADA (b)(4)) was adulterated due to extralabel use. The drug was administered to the dairy cow without following approved labeling indications and without the supervision of a licensed veterinarian, violating 21 CFR 530.11(a). An