A Minnesota dairy farm received an April 19 warning letter from the U.S. Food and Drug Administration after state agriculture officials conducted an investigation into animal drug misuse.
The letter says violations of the Federal Food, Drug and Cosmetic Act were discovered during the investigation last Dec. 6-7 by the Minnesota Department of Agriculture.
The findings involve Durst Brothers Inc., a dairy located in Mantorville, MN. FDA says the dairy misused new animal drugs known as penicillin G procaine and tilmicosin.
Both antibiotics, penicillin G procaine combats infection, and tilmicosin is used to treat and prevent pneumonia in cattle, sheep, and pigs.
The state investigation found both drugs were not being used as directed. Animal drugs like penicillin G procaine and tilmicosin must be used as the label directs, unless there is a lawful order from a licensed veterinarian who is directly involved in the animal’s care.
FDA accuses Durst Brothers of administering penicillin G procaine without following the dosing instructions. FDA said because that dosing was not under the supervision of a licensed veterinarian, it was a violation of federal law.
Investigators said they found that tilmicosin was injected into a dairy cow, although the drug is not approved for use in dairy cattle that are 20 months of age or older, and that the drug was administrated without the supervision of a licensed veterinarian. That, too, is violation of federal law.
“The above is not intended to be an all-inclusive list of violations,” the warning letter said. “As a producer of animals offered for the use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.”
“You should take prompt action to correct the violations described in this letter, and to establish procedures to ensure that these violations do no recur,” it continued. “Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.”
Durst Brothers was given 15 working days to correct the violations and was told to work with FDA’s Minneapolis compliance officer.