Riedstra Dairy, Ltd. – FDA Warning Letter, Nov 2, 2021

On February 4, 2022, the FDA issued a Warning Letter to Riedstra Dairy, Ltd. following an inspection from September 2 to November 2, 2021. The letter details violations of the Federal Food, Drug, and Cosmetic Act.

The FDA found that Riedstra Dairy offered an adulterated animal for human consumption. Specifically, on November 16, 2020, a cow sold for slaughter contained desfuroylceftiofur at 0.568 ppm in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 CFR § 556.113(b)(1)(i)). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the farm was cited for insanitary conditions (21 U.S.C. § 342(a)(4)) due to an inadequate system to prevent medicated animals with harmful drug residues from entering the food supply. Deficiencies included incomplete and inaccurate treatment records (e.g., unrecorded treatments, missing routes of administration) and a lack of a drug inventory system.

The new animal drug (b)(4) (ceftiofur hydrochloride) was also found to be adulterated (21 U.S.C. § 351(a)(5)) due to extra-label