Ulrich Farms – FDA Warning Letter, Oct 21, 2021

On February 7, 2022, the FDA issued a Warning Letter to a dairy operation in Dresser, Wisconsin, following an inspection on October 6 and 21, 2021. The letter details violations of the Federal Food, Drug, and Cosmetic Act.

The operation offered an adulterated animal for slaughter. On May 10, 2021, a cow sold for slaughter contained ampicillin at 0.08 ppm in kidney tissue, exceeding the 0.01 ppm tolerance, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the operation held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). This was due to an inadequate system for ensuring proper drug withdrawal times. Specifically, treatment records lacked dosage, route, indication, milk/meat withhold times, and administrator's name.

The inspection also revealed the new animal drug (b)(4) (ampicillin) was rendered unsafe and adulterated under sections 512 and 501(a)(5) due to extralabel use not conforming to approved labeling or 21 CFR Part 530. The drug was administered without licensed veterinarian supervision, violating 21 CFR 530.11(a). It was used