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Talk to a SpecialistTalk to a SpecialistMike Millenkamp Dairy Cattle was cited for adulterating the new animal drug enrofloxacin by administering it to a beef steer ten times over a thirty-day period starting in December 2021 to treat Mycoplasma bovis, which constituted prohibited extralabel use of a fluoroquinolone. The approved label for enrofloxacin in cattle specifies only a single subcutaneous dose followed by a 28-day withdrawal period, whereas the operation's repeated dosing regimen did not conform to this labeling. This violation rendered the drug unsafe and adulterated under the Federal Food, Drug, and Cosmetic Act, specifically violating 21 CFR § 530.41(a)(10), which prohibits extralabel use of fluoroquinolones in animals. The company failed to respond to the FDA 483 Inspectional Observations issued at the close of the August 2022 inspection.