Martin Farm, Konrad Martin – FDA Warning Letter, Jun 21, 2023

On November 14, 2023, the FDA issued a Warning Letter to a dairy operation in Nappanee, Indiana, following inspections on May 24 and June 21, 2023. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act, for which no response to the issued FDA 483 form has been received.

The primary violations include the adulteration of animals offered for human consumption due to inadequate conditions and incomplete treatment records. Specifically, the operation lacks treatment records for drugs administered to calves and maintains incomplete records for cattle, missing details such as dose, total treatment days, route of administration, and the person administering the medication. This renders the food adulterated under section 402(a)(4) of the FD&C Act.

Furthermore, the operation engaged in the extra-label use of new animal drugs, specifically (b)(4) (enrofloxacin) and (b)(4) (ceftiofur hydrochloride), which is prohibited. (b)(4) was administered to calves for unapproved indications (scours and respiratory disease prevention), via unapproved routes (IM or orally with milk), and without observing meat withdrawal periods, despite being prohibited for extra-label use (21 CFR 530.41(a)(10)). (b)(4) was used at an incorrect dose, exceeding the labeled maximum per injection site, also a prohibited extra