FDA WARNING_LETTER - Mike Millenkamp Dairy Cattle - August 05, 2022

On November 28, 2022, the FDA issued a Warning Letter to Mike Millenkamp Dairy Cattle following an inspection on August 2 and 5, 2022, at their beef cattle growing operation in Earlville, Iowa. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation identified was the adulteration of the new animal drug enrofloxacin. Specifically, a beef steer (ear tag (b)(4)) was administered enrofloxacin 10 times over a thirty-day period starting December 21, 2021, to treat Mycoplasma bovis. This constitutes an extralabel use, as no approved enrofloxacin drug is labeled for multiple uses for Mycoplasma bovis treatment in cattle. The only labeled use is a single subcutaneous dose with a 28-day withdrawal time. Fluoroquinolones, including enrofloxacin, are prohibited from extralabel use under 21 CFR § 530.41(a)(10). This extralabel use rendered the drug unsafe under section 512(a) of the FD&C Act (21 U.S.C. § 360(b)(a)) and adulterated under section 501(a)(5) of the FD&C Act (21 U.S.C. § 351