Warning Letter Record: Allandale Dairy (2026-06-23) — New Animal Drug/Adulterated
Letter issued · posted to fda.gov .
Subject as published: New Animal Drug/Adulterated
TL;DR
In short: The FDA Center for Veterinary Medicine issued Warning Letter CMS #727610 to Allandale Dairy (Shane D. Stangl, Scott Stangl, and Craig Stangl, co-owners) on June 23, 2026, following inspections on March 3, 11, and 19, 2026. The letter cites violations including sale of a dairy cow with sulfadimethoxine residues (0.116 ppm in liver tissue) exceeding FDA's 0.1 ppm tolerance; inadequate treatment records for medicated animals; and extralabel administration of sulfadimethoxine injection and flunixin meglumine injection in violation of approved labeling and veterinary prescriptions. The agency states that Allandale Dairy did not respond to the FDA 483 Inspectional Observations form issued at the close of inspection.
Argus analysis
# FDA Warning Letter Analysis: Allandale Dairy
**Company and Violations**
Allandale Dairy, a Minnesota-based operation owned by Shane D. Stangl, Scott Stangl, and Craig Stangl, received a warning letter from the FDA's Center for Veterinary Medicine on June 23, 2026, following inspections in March 2026. The FDA documented two primary violations: the sale of an animal with drug residues exceeding safe tolerance levels for human consumption, and extralabel use of prescription animal drugs without proper compliance. Specifically, a cow sold for slaughter contained sulfadimethoxine residue at 0.116 ppm in liver tissue, exceeding the established tolerance of 0.1 ppm.
**Regulatory Citations and Implications**
The violations cite 21 CFR 556.640 (drug tolerance standards), 21 CFR 530 (extralabel drug use requirements), and sections 402 and 512 of the Federal Food, Drug, and Cosmetic Act regarding adulterated foods and unsafe drugs. The FDA found two key problems: incomplete treatment records lacking details on conditions treated, administration routes, and personnel responsible; and improper dosing of sulfadimethoxine and flunixin meglumine, with animal weights applied inconsistently across treatment sessions. These violations indicate systemic gaps in drug administration oversight and documentation practices at the farm level.
**Response Timeline and Industry Monitoring**
Allandale Dairy has 15 working days to submit written corrective actions, including documentation of steps taken and timelines for completion. Compliance officers in the dairy industry should monitor whether the operation implements enhanced record-keeping systems, weight-based dosing protocols, and veterinary oversight mechanisms. The FDA copied Minnesota Department of Agriculture and the Office of Dairy and Seafood Safety, signaling potential state-level enforcement coordination. Failure to demonstrate adequate remediation may result in regulatory or legal 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 Allandale Dairy MARCS-CMS 727610 — June 23, 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 Shane D. Stangl, Scott Stangl and Craig Stangl Recipient Title Co-Owner(s) Allandale Dairy 27231 83rd Street Pierz , MN 56364 United States shane.stangl@gmail.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER CMS # 727610 June 23, 2026 Dear Messrs. Stangl, On March 3, March 11 and March 19, 2026, a representative of the U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation located at 27231 83rd Street, Pierz, Minnesota. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your operation. At the close of the inspection, you were issued Form FDA 483, Inspectional Observations (FDA 483). We have not received a response to the FDA 483 as of the date of this letter. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s web page at www.fda.gov. Adulteration of an Animal Offered for Human Consumption We found you offered for sale an animal for slaughter as food that was adulterated. Specifically, you sold a cow identified with backtag (b)(4) 1 at auction on or about (b)(4) . The animal was slaughtered on or about (b)(4) , by (b)(4) in (b)(4) . The U.S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of sulfadimethoxine at 0.116 parts per million (ppm) in liver tissue. FDA has established a tolerance of 0.1 ppm of sulfadimethoxine, in the edible tissue of cattle. 2 The presence of this drug in the edible tissues of this animal at this level causes the food to be adulterated. A food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe. 3 A drug is unsafe if it results in any residues that exceed any established safe levels. 4 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act. 5 Additionally, our inspection also 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. For instance, you did not maintain complete treatment records for drugs administered to cattle at your dairy. Specifically, your treatment records do not consistently list the condition treated, route of administration, or who administered the drug. Food from animals held under such conditions whereby it may have been rendered injurious to health is adulterated. 6 Adulteration of New Animal Drugs Our inspection found you did not use Sulfadimethoxine Injection 40% ( (b)(4) ) and (b)(4) (flunixin meglumine injection, (b)(4) ) as directed by their approved l…
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 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.
- Has Allandale Dairy had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Allandale Dairy as of 2026-07-14. Argus ingests new FDA enforcement records daily.
- What FDA violations was Allandale Dairy cited for?
- The FDA Warning Letter to Allandale Dairy (issuing office: Center for Veterinary Medicine) cites: New Animal Drug/Adulterated. Classification: Warning Letter.
- When did FDA issue the warning letter to Allandale Dairy?
- FDA issued the letter (MARCS-CMS 727610) on 2026-06-23 and posted it publicly on fda.gov on 2026-07-14.
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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). Warning Letter Record: Allandale Dairy (2026-06-23) — New Animal Drug/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-allandale-dairy-2026-06-23-warning-letter
"Warning Letter Record: Allandale Dairy (2026-06-23) — New Animal Drug/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-allandale-dairy-2026-06-23-warning-letter.
Argus HQ Research. "Warning Letter Record: Allandale Dairy (2026-06-23) — New Animal Drug/Adulterated." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/fda/warning-letter/fda-wl-allandale-dairy-2026-06-23-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_allandale_dairy_2026_06_23_warning_letter_2026,
title = {Warning Letter Record: Allandale Dairy (2026-06-23) — New Animal Drug/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-allandale-dairy-2026-06-23-warning-letter},
note = {Accessed: July 15, 2026}
}