DeJong Family Dairy, LLC — FDA Warning Letter, 2026-07-30: New Animal Drug/Adulterated
Letter issued · posted to fda.gov .
Subject as published: New Animal Drug/Adulterated
TL;DR
Here's the summary: The FDA Center for Veterinary Medicine issued a warning letter (CMS #729293) to DeJong Family Dairy, LLC on July 30, 2026, following inspections on April 6-8, 2026, citing violations of the Federal Food, Drug, and Cosmetic Act for extralabel use of an intramammary infusion drug. The dairy administered the drug to multiple cows in a manner not consistent with approved labeling and without a licensed veterinarian's order, rendering the drug unsafe and adulterated. The FDA requested corrective action within 15 working days, including employee training documentation and treatment records demonstrating proper medication use.
Argus analysis
# FDA Warning Letter Analysis: DeJong Family Dairy, LLC
**Company Background and Violations**
DeJong Family Dairy, LLC, a Wisconsin-based dairy operation owned by Markus J. DeJong, received a warning letter from the FDA's Center for Veterinary Medicine on July 30, 2026, following an inspection on April 6 and 8, 2026. The FDA identified significant violations involving the extralabel use of an approved intramammary infusion drug. Specifically, the agency documented three instances where dairy cows were treated with medication in a manner inconsistent with the drug's approved labeling and without veterinary authorization.
**Regulatory Citations and Implications**
The violations center on 21 CFR 530.11(a), which governs extralabel drug use in animals. Federal regulations permit extralabel use only when issued by a licensed veterinarian within a valid veterinarian-client-patient relationship and in compliance with the FD&C Act. DeJong's treatment protocol—administering single syringes once daily for three consecutive days—deviated from manufacturer directions. By failing to obtain veterinary authorization for this off-label use, the facility caused the drugs to be classified as adulterated under section 501(a)(5) of the FD&C Act. The FDA also noted that the facility's April 13, 2026 response lacked sufficient documentation regarding employee training and treatment records.
**Response Timeline and Industry Monitoring**
DeJong has fifteen working days from receipt to submit written corrective actions with supporting documentation. Compliance officers in the dairy industry should monitor whether the facility provides evidence of veterinary consultation protocols, employee training programs, and revised treatment records. The inclusion of the Division of Dairy Safety on the warning letter's copy list signals continued scrutiny. Failure to demonstrate systemic corrective measures could escalate to enforcement action.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER DeJong Family Dairy, LLC MARCS-CMS 729293 — July 30, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL NO HARD COPY TO FOLLOW Product: Animal & Veterinary Recipient: Recipient Name Markus J. DeJong Recipient Title Owner DeJong Family Dairy, LLC 3398 Draper Road Dorchester , WI 54425 United States markus.dejong@icloud.com Issuing Office: Center for Veterinary Medicine United States 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 adultera…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What FDA violations was DeJong Family Dairy, LLC cited for?
- The FDA Warning Letter to DeJong Family Dairy, LLC (issuing office: Center for Veterinary Medicine) cites: New Animal Drug/Adulterated. Classification: Warning Letter.
- When did FDA issue the warning letter to DeJong Family Dairy, LLC?
- FDA issued the letter (MARCS-CMS 729293) on 2026-07-30 and posted it publicly on fda.gov on 2026-08-18.
- Is the FDA warning letter to DeJong Family Dairy, LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dejong-family-dairy-llc-729293-07302026.
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). DeJong Family Dairy, LLC — FDA Warning Letter, 2026-07-30: New Animal Drug/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-dejong-family-dairy-llc-2026-07-30-warning-letter
"DeJong Family Dairy, LLC — FDA Warning Letter, 2026-07-30: New Animal Drug/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-dejong-family-dairy-llc-2026-07-30-warning-letter.
Argus HQ Research. "DeJong Family Dairy, LLC — FDA Warning Letter, 2026-07-30: New Animal Drug/Adulterated." Digital Empire Holdings LLC. Accessed August 21, 2026. https://argushq.ai/fda/warning-letter/fda-wl-dejong-family-dairy-llc-2026-07-30-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_dejong_family_dairy_llc_2026_07_30_warning_letter_2026,
title = {DeJong Family Dairy, LLC — FDA Warning Letter, 2026-07-30: New Animal Drug/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-dejong-family-dairy-llc-2026-07-30-warning-letter},
note = {Accessed: August 21, 2026}
}