Joe L. Pimentel Dairy – FDA Warning Letter, Sep 12, 2011

On October 27, 2011, the FDA issued a Warning Letter to Joe L. Pimentel Dairy following an investigation conducted on September 2, 9, and 12, 2011. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on May 26, 2011, the dairy sold a cow for slaughter that was found to have sulfadimethoxine in its liver tissue at 0.41 ppm, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. 556.640). This rendered the animal's food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, 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 dairy engaged in extralabel use of sulfadimethoxine by not following approved labeling dosage, which is prohibited in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and resulted in an illegal drug residue, violating 21 C.F.R.