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WARNING LETTER
FY22-HAFE6-07 CMS 631036

June 24, 2022

FEI: 3015158417
CMS Case: 631036

Dear Mr. Grate:

An inspection of your dairy operation Brad Grate Dairy Farm located at 3035 County Road 14, Waterloo, Indiana, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on March 2, 8, 15 and 17, 2022. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s webpage at www.fda.gov.

Adulteration of an Animal Offered for Human Consumption

Our investigation found that you offered for sale an animal for slaughter as food that was adulterated. On or about March 31, 2021, you sold a cow identified with ear bangle (b)(6), and back tag (b)(6) for slaughter as food. The animal was slaughtered on or about (b)(6), at (b)(4). The United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 2.59 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur, a metabolite breakdown of ceftiofur class drugs, in uncooked edible kidney tissues of cattle as codified in Title 21, Code of Federal Regulations § 556.113(b)(1)(i) [21 CFR § 556.113(b)(1)(i)]. The presence of this drug in edible tissue from this animal at this level causes the food to be adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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. Under section 512(a)(4)(B) of the FD&C Act [21 U.S.C. § 360b(a)(4)(B)], a drug is unsafe if it results in any residues that exceed any established safe levels. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C § 331(a)].

Additionally, you caused the food to be adulterated under section 402(a)(4) of the FD&C Act [21 U.S.C. 342(a)(4)], which deems a food 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 inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to maintain complete and accurate treatment records. Your records do not routinely include the route of administration for treatments or identify the individual administering the treatment. Your records also fail to consistently document the drug dose administered to an animal.

Furthermore, you also do not maintain a drug inventory system for determining the quantities of drugs used to medicate your cows.

Adulteration of a New Animal Drug

Our investigation found that you used (b)(4) and Ampicillin Trihydrate (NADA 200-180) to treat cattle contrary to their label instructions. For example, on 03/03/2021 you used (b)(4) to treat a cow for retained placenta. In addition, on several occasions you used Ampicillin Trihydrate to treat cows for metritis and retained placenta. These drugs are not labeled for these conditions in food-producing animals. Use of a drug in a manner that is not consistent with its labeling is an extra-label use, as defined by 21 CFR § 530.3(a). The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with sections 512(a)(4) and (5) of the FD&C Act [21 U.S.C. §§ 360b(a)(4) and (5)], and 21 CFR § 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship as defined by 21 CFR § 530.3(i)(1). However, your extra-label use of (b)(4) and Ampicillin Trihydrate were not under the supervision of a licensed veterinarian, in violation of 21 CFR § 530.11(a). The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C § 331(a)].

Our investigation also found that you adulterated (b)(4) NADA (b)(4) by administering it in an extra-label manner by routinely injecting it in the (b)(4). The on-label directions for use for this drug indicate the route of administration to be in the (b)(4). (b)(4) is a cephalosporin antibiotic, which is prohibited from extra-label use at unapproved routes of administration in food-producing animals per 21 CFR § 530.41(a)(13)(ii).

Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, you caused the drugs to be unsafe under sections 512(a)(4) and 512 (a)(5) of the FD&C Act [21 U.S.C. § 360b(a)(4)(A)] and adulterated under section 501(a)(5) of the FD&C 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. You are responsible for investigating and determining the cause of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

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, including without limitation, seizure and/or injunction.

We also have the following comment:

During the inspection, our investigator noted that the dosage of medications recorded in your treatment records was different from your verbal statements to the investigator about your typical dosage. It is important that the treatment record accurately reflect the actual dosage of the drug given to an animal. This helps ensure the animals are being given the appropriate dosage for treatment, can help avoid potentially illegal extralabel drug use, and can help identify the need for extended milk and/or meat withdrawal times.

Within fifteen (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 prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (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 FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

To date, we have not received any correspondence from you addressing the inspectional observations or the steps you are taking to correct these issues.

Your written response should be sent to Dylan C. Grippi, Acting Compliance Officer, at 300 River Place Drive, Suite 5900, Detroit, MI 48207 or via email (preferred) to Dylan.Grippi@fda.hhs.gov. If you have any questions about this letter, please contact Mr. Grippi at (301)-452-1608, or by e-mail at Dylan.Grippi@fda.hhs.gov.

Sincerely,

/S/

William R. Weissinger, MS
District Director | FDA Chicago District
Program Division Director
Office of Human and Animal Food Operations East Division 6

 

CC:

Dr. David J. Hargarten, DVM
Auburn Hills Animal Hospital
3120 County Rd. 36
Auburn, IN 46706
auburnhills.vets@gmail.com