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WARNING LETTER
CMS 664784

November 14, 2023

Mailing Address:
(b)(6), (b)(7)(C)

Dear Mr. Martin:

An inspection of your dairy operation located at 68572 Country Road 46, Nappanee, Indiana, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on May 24, 2023, and June 21, 2023. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our inspection 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.

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 of this letter.

Adulteration of an Animal Offered for Human Consumption

Our inspection 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 failed to maintain complete and accurate treatment records. For example, you do not maintain any treatment records for drugs administered to calves on your farm, nor do you keep complete treatment records of drugs administered to cattle on your farm as those records lack dose, total days of treatment, route of administration, and person medicating animal and calves.

Food held under such conditions is adulterated.¹

 Adulteration of a New Animal Drug

We also found that you did not use (b)(4) (enrofloxacin, (b)(4)) and (b)(4) (ceftiofur hydrochloride, (b)(4)) as directed by their approved labeling and prescription labels. Use of a drugs in a manner that is not consistent with its labeling is an extralabel use.²

Our inspection found that you administered (b)(4) to calves without following the animal class, indications for use, route of administration, and withdrawal time. During the inspection, you stated that you administer (b)(4) of (b)(4) to prevent and treat scours and respiratory disease in most calves, either intramuscularly (IM) or orally with milk, and you do not follow meat withdrawal periods. This drug is not approved for use in calves or for disease prevention purposes for scours, and cannot be administered IM or orally or used without a meat withhold period. Extra-label use of (b)(4) is prohibited.³

Our inspection also found that you used (b)(4) without following the labeled dose. For example, during the inspection you explained that you used (b)(4) by giving (b)(4). This drug is labeled for administering no more than (b)(4) per injection site. (b)(4), a ceftiofur class drug, is prohibited from extra label use.⁴

Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the drugs to be unsafe and adulterated.⁵ The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.⁶

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.

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 Dylan C. Grippi, 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
Program Division Director
Office of Human and Animal Food Operations East Division 6

CC: (b)(4)

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1 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)]

2 See 21 CFR 530.3(a).

3 See 21 CFR 530.41(a)(10).

4 See 21 CFR 530.41(a)(13)(ii).

5 Under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], a new animal drug is deemed adulterated if it is unsafe within the meaning of section 512 of the FD&C Act [21 U.S.C. § 360b].

6 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]