FDA WARNING_LETTER - Marion Mullet Farm - June 22, 2023

On November 28, 2023, the FDA issued a Warning Letter to a calf dealer in Goshen, IN, following an inspection on June 9 and June 22, 2023. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

The primary violations include: 1. **Adulteration of an Animal Offered for Human Consumption:** The facility failed to maintain complete and accurate treatment records for drugs administered to calves. This omission creates conditions where medicated animals with potentially harmful drug residues could enter the food supply, rendering the food adulterated under section 402(a)(4) of the FD&C Act. 2. **Adulteration of a New Animal Drug:** The facility administered Sulfamethoxazole and Trimethoprim Tablets contrary to the veterinarian's prescription. The veterinarian prescribed specific dosages and a meat withdrawal period for treating and preventing diarrhea, pneumonia, and ear infections. However, the owner stated administering the drug orally to most calves based on their appearance and was not concerned about withdrawal periods, informing buyers that calves might be medicated. This constitutes extra-label drug use not in compliance with 21 CFR § 530, specifically failing to follow the veterinarian's lawful order within a valid veterinarian/client/patient relationship. This made the drug unsafe and adulterated under section 501(a)(5) of the FD&C Act.