---

---

---

WARNING LETTER
CMS 665227

November 28, 2023

Dear Mr. Mullet:

On June 9, 2023 and June 22, 2023, a representative of the U.S. Food and Drug Administration conducted an inspection of your calf dealer located at 61584 County Road 33, Goshen, IN. 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 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 of this letter.

Adulteration of an Animal Offered for Human Consumption

Our inspection 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 because you failed to maintain complete and accurate treatment records. Specifically, you do not maintain any treatment records for drugs administered to calves on your farm. Food held under conditions whereby it may have been rendered injurious to health is adulterated.¹

Adulteration of a New Animal Drug

Our inspection found that you adulterated Sulfamethoxazole and Trimethoprim Tablets ((b)(4)), by administering this drug contrary to the prescription from your veterinarian. The prescription by your veterinarian was to use this drug for the treatment and prevention of diarrhea (scours), pneumonia, & ear infection by administering (b)(4) tablets every (b)(4) with a (b)(4) meat withdrawal period. During the inspection, you stated that you administer (b)(4) tablets orally to most calves based on how they look when you purchase them and that you are not concerned about meat withdrawal periods because you inform buyers that calves might be medicated. Use of a drug in a manner not consistent with its labeling is extralabel use. 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). Your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 530 because you did not follow your veterinarian’s prescription. You therefore caused the drug to be unsafe and adulterated.²

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 causes 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 action, 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 frame 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)

________________________

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

2 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].