FDA Warning Letter to Golden Dakota Farms LLC (2026-05-20) — New Animal Drug/Adulterated
Letter issued · posted to fda.gov .
Subject as published: New Animal Drug/Adulterated
TL;DR
Key takeaway: The FDA's Center for Veterinary Medicine issued Warning Letter CMS #725317 on May 20, 2026, to Golden Dakota Farms LLC (owners Nicholas Coetzee and Eric Goedhart, Elkton, South Dakota) following an inspection conducted January 26-29, 2026. The FDA found the operation sold dairy cows for human consumption with violative ampicillin residues exceeding the 0.01 ppm tolerance (detected at levels up to 1.68 ppm), failed to maintain complete treatment records for medicated animals, administered antibiotics at doses exceeding veterinary prescriptions without veterinary consultation, and operated under insanitary conditions allowing drug residues into the food supply. The company's proposed corrective actions (weight measurement protocols, withhold time reviews, treatment record improvements) were deemed insufficient due to lack of supporting documentation.
Argus analysis
# FDA Warning Letter Analysis: Golden Dakota Farms LLC
**The Violation**
Golden Dakota Farms LLC, a dairy operation in Elkton, South Dakota, received a warning letter from FDA's Center for Veterinary Medicine on May 20, 2026, following an inspection conducted January 26–29, 2026. The agency identified the sale of dairy cattle for human slaughter that contained violative ampicillin residues in edible tissue, exceeding FDA's established tolerance of 0.01 ppm. Two cows tested positive: one with ampicillin at 1.68 ppm in muscle tissue and 0.0898 ppm in kidney tissue; another with 0.0242 ppm in kidney tissue. The inspection also documented incomplete treatment records for medicated animals, including instances where antibiotics were administered without documented dosage or veterinary consultation.
**Regulatory Citations**
The violations centered on 21 CFR 556.40(b), which establishes ampicillin tolerances in cattle tissue, and 21 CFR 530.11(a), governing extralabel drug use. Ampicillin residues exceeding tolerance levels render food adulterated under FD&C Act Section 402(a)(2)(C)(ii). The operation also violated extralabel use requirements by administering an antibiotic at higher-than-prescribed doses without veterinary supervision and without maintaining a valid veterinarian-client-patient relationship, violating FD&C Act Section 512(a)(4)(B).
**Next Steps and Industry Monitoring**
Golden Dakota Farms had 15 working days from letter receipt to submit written corrective actions to compliance officer Andrew J. Howard. The FDA noted the initial February 11, 2026 response lacked supporting documentation demonstrating consistent implementation of proposed improvements. Peer compliance officers in dairy operations should monitor whether the company provides adequate proof of corrective measures—including weight-based dosing protocols, revised treatment records, withhold-time tracking systems, and veterinary consultation procedures—before resuming sales to slaughter facilities.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
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 Golden Dakota Farms LLC MARCS-CMS 725317 — May 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Animal & Veterinary Recipient: Recipient Name Nicholas Coetzee, Owner Recipient Title Eric Goedhart, Owner Golden Dakota Farms LLC 48188 221st Street Elkton , SD 57026-5059 United States (b)(6), (b)(7)(C) Issuing Office: Center for Veterinary Medicine United States WARNING LETTER CMS # 725317 May 20, 2026 Dear Messrs. Coetzee and Goedhart, The United States Food and Drug Administration (FDA) conducted an inspection of your dairy operation located at 48188 221st Street, Elkton, South Dakota, between January 26 and January 29, 2026. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were revealed during the inspection. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge your written response received February 11, 2026, and address your proposed corrections below. 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. Adulteration of an Animal Offered for Human Consumption Our inspection found you offered for sale a dairy cow for slaughter as food that was adulterated. Specifically, on (b)(4) , you sold a dairy cow identified with ear tag (b)(4) . This cow was slaughtered to be used as food at (b)(4) in (b)(4) on (b)(4) . United States Department of Agriculture/Food Safety Inspection Services (USDA/FSIS) analysis of edible tissue revealed the presence of ampicillin at 1.68 parts per million (ppm) in muscle tissue and 0.0898 ppm in kidney tissue. Additionally, on (b)(4) , you sold a dairy cow identified with ear tag (b)(4) . This cow was slaughtered to be used as food at (b)(4) in (b)(4) on (b)(4) . USDA/FSIS analysis of kidney tissue revealed the presence of ampicillin at 0.0242 ppm. FDA has established a tolerance of 0.01 ppm of ampicillin in edible tissue for cattle. 1 The presence of this drug in edible tissue from animals at these levels cause the food to be adulterated. A food is deemed adulterated if it bears or contains a new animal drug that is unsafe. 2 A drug is unsafe if it results in any residues that exceed established safe levels. 3 Additionally, our investigation found that you hold animals under insanitary conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you did not maintain complete and accurate treatment records for cattle that you medicate: You had no records documenting you treated a dairy cow with ear tag (b)(4) using antibiotics. You indicated that you may have treated the cow in error with (b)(4) . The cow with ear tag (b)(4) was sold for slaughter for human food on (b)(4) , and found to contain a violative ampicillin residue in kidney tissue at the time of slaughter on …
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
- Is the FDA warning letter to Golden Dakota Farms 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/golden-dakota-farms-llc-725317-05202026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a Warning Letter warning letter?
- 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 is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
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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). FDA Warning Letter to Golden Dakota Farms LLC (2026-05-20) — New Animal Drug/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-golden-dakota-farms-llc-2026-05-20-warning-letter
"FDA Warning Letter to Golden Dakota Farms LLC (2026-05-20) — New Animal Drug/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-golden-dakota-farms-llc-2026-05-20-warning-letter.
Argus HQ Research. "FDA Warning Letter to Golden Dakota Farms LLC (2026-05-20) — New Animal Drug/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-golden-dakota-farms-llc-2026-05-20-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_golden_dakota_farms_llc_2026_05_20_warning_letter_2026,
title = {FDA Warning Letter to Golden Dakota Farms LLC (2026-05-20) — New Animal Drug/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-golden-dakota-farms-llc-2026-05-20-warning-letter},
note = {Accessed: July 13, 2026}
}