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February 7, 2022

WARNING LETTER

Refer to CMS 622336

Dear Messrs. Ulrich:

An inspection of your dairy operation located at 950 – 180th Street, Dresser, Wisconsin, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on October 6 and 21, 2021. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were revealed during our inspection of your operation and upon further review of the information collected during the inspection. You can find the Act and its associated regulations on the internet through links on the FDA’s web page at www.fda.gov.

Adulteration of an Animal Offered for Human Consumption:
We found that you offered an animal for sale for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act (21 U.S.C. § 342(a)(2)(C)(ii)), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe. A new animal drug is unsafe if it causes a residue in an animal that exceeds any tolerance established for that drug as a result of extralabel use. See section 512(a)(4)(B) of the Act (21 U.S.C. § 360b(a)(4)(B)).

On or about May 10, 2021, you sold a cow identified with ear tag (b)(6) for slaughter as food at (b)(4), located in (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of ampicillin at 0.08 parts per million (ppm) in the kidney tissue. A tolerance of 0.01 ppm has been established for residues of ampicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR). The presence of this drug in edible tissue from this animal at 0.08 ppm causes the food to be adulterated.

Further, under section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health. Our investigation found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records that include the dosage administered, the route of administration, indication for use, milk and meat withhold times, and name of person administering treatment.

Adulteration of a New Animal Drug:
Our inspection also revealed that you caused the drug (b)(4) (ampicillin, (b)(4)) to become unsafe under section 512 of the Act (21 U.S.C. § 360b) and adulterated under section 501(a)(5) of the Act (21 U.S.C. § 351(a)(5)).

Specifically, you failed to use the drug in conformance with its approved labeling (“extralabel use”). Extralabel use is only permitted if the use complies with sections 512(a)(4) and 512(a)(5) of the Act, and with 21 CFR Part 530, including that the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Our investigation found that your extralabel use of (b)(4) failed to comply with these requirements.

For example, you administered (b)(4) and did not follow the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, you administered (b)(4) for stomach issues whereas this drug is labeled for treatment of bovine respiratory disease. Further, you administered (b)(4) for one day whereas the label states to administer (b)(4).

Your extralabel use also resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a)(4)(A) of the Act (21 U.S.C. § 360b(a)(4)(A)) and adulterated under section 501(a)(5) of the Act (21 U.S.C. § 351(a)(5)).

Conclusion:
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute comply with the law.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action without further notice, such as seizure and/or injunction.

Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete the corrective actions within 15 working days, state the reason for the delay and the time within which you will complete the correction. If you believe that you have complied with the Act and FDA regulations, include your reasoning and any supporting documentation for our consideration.

Your written response should be sent to Boun M. Xiong, Compliance Officer, U.S. Food and Drug Administration, at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.

Sincerely,
/S/

Michael Dutcher, DVM
Director, Division 1 West
Office of Human and Animal Food Operations