Mike Millenkamp Dairy Cattle

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November 28, 2022

RE: CMS CASE 640782

WARNING LETTER

Dear Mr. Millenkamp:

An inspection of your beef cattle growing operation Mike Millenkamp Dairy Cattle located at 2065 137th Street, Earlville, Iowa, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on August 2 and 5, 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 Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.

At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We have not received a response to the FDA 483 as of the date on this letter.

Adulteration of a New Animal Drug

Our investigation found that you adulterated the new animal drug enrofloxacin (b)(4) by administering it to a beef steer, identified with ear tag (b)(4), without following the duration of use for the treatment as stated in the approved label. Specifically, you administered enrofloxacin 10 times during a thirty-day period starting on or about December 21, 2021 to treat a beef steer (ear tag (b)(4)) for Mycoplasma bovis. No approved drug containing enrofloxacin is labeled for multiple uses for the treatment of Mycoplasma bovis in cattle. Use of this drug in this manner is an extralabel use, as defined by Title 21, Code of Federal Regulations § 530.3(a) [21 CFR § 530.3(a)]. The only labeled use of enrofloxacin, for the treatment of Mycoplasma bovis in cattle, is a single subcutaneous dose followed by 28 days of withdrawal time.

Under 21 CFR § 530.41(a)(10), fluoroquinolones, which include enrofloxacin, are prohibited from extralabel use. Because your use of this drug was not in conformance with the approved label and labeling, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360(b)(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). The doing of any act to a drug after shipment of the drug and or/its components in interstate commerce while the drug is held for sale (whether or not the first sale) that results in the drug being adulterated or misbranded is a prohibited act under section 301(k) of the FD&C Act [21 U.S.C § 331(k)].

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 injunction.

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.

Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214-1524. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154, or Danial.Hutchison@fda.hhs.gov.

Sincerely yours,
/S/

LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food
West Division II

cc:

Iowa Department of Inspections and Appeals
Larry Johnson, JR, Director
515-281-5457
larry.johnson@dia.iowa.gov