DeJong Family Dairy, LLC

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WARNING LETTER
CMS # 729293

July 30, 2026

Dear Markus J. DeJong,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation, located at 102218 Draper Road, Dorchester, Wisconsin 54425 on April 6 and April 8, 2026. This letter notifies you of the significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were found during our inspection of your operation. You can find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We received your response dated April 13, 2026, and have reviewed them below in relation to each noted violation.

Adulteration of New Animal Drugs
Our inspection found you did not use (b)(4) ((b)(4)) for intramammary infusion in accordance with its approved labeling and your veterinary prescription. Use of a drug in a manner that is not consistent with its labeling is extralabel use.¹

The manufacturer’s label for (b)(4)® states, “(b)(4)”. However, our inspection found that your treatment of multiple cows failed to conform with these directions. You administered one syringe once a day in affected quarters for three consecutive days for the following cows:

• Cow with ear tag (b)(4) was treated once a day with one syringe in affected quarters on August 15 through 17, 2025.
• Cow with ear tag (b)(4) was treated once a day with one syringe in affected quarters on August 22 through 25, 2025.
• Cow with ear tag (b)(4) was treated once a day with one syringe in affected quarters on January 11 through 13, 2026.

Since you did not follow the labeled directions, you used the drug in an extralabel manner. The extralabel use of approved animal or human drugs is only allowed if the extralabel use complies with the FD&C Act, 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,² and 21 CFR 530.³ Your extralabel use of this drug was not done in accordance with an order from a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your extralabel use of this drug was not in compliance with the FD&C Act and 21 CFR 530, you caused the drugs to be unsafe and adulterated.⁴ The doing of any act to a food or drug after shipment of the food or drug and/or its components in interstate commerce and while the food or drug is held for sale (whether or not the first sale) that results in the food or drug being adulterated or misbranded is a prohibited act.⁵

Evaluation of your response:
We reviewed your emailed response dated April 13, 2026. Your response does not provide enough details for us to adequately evaluate the effectiveness and sustainability of your actions. You did not provide supporting documentation that you trained your employees in the proper use of the medications they administer to your animals. You also did not provide supporting documentation, such as treatment records, demonstrating the correct use of (b)(4) and other drugs at your dairy.

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 you comply with all requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you with an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address any violation may lead to regulatory, or where appropriate, legal action.

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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.

The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.

Please direct your electronic correspondence to Compliance Officer Stephen J. Rabe at Stephen.rabe@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Stephen J. Rabe by email or telephone at 513-322-0660.

/S/

Isaac K. Carney
Director of Food Compliance, Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration

CC:
Janet McGinn, Director
Division of Dairy Safety
Office of Dairy and Seafood Safety
Human Food Program
Janet.mcginn@fda.hhs.gov

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1 See 21 CFR 530.3(a).

2 See 21 CFR 530.3(i).

3 See section 512(a)(4) and Section 512(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a)(4) and 360b(a)(5)].

4 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].

5 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].