WARNING LETTER

Allandale Dairy MARCS-CMS 727610 — June 23, 2026

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 labeling and your veterinary prescriptions. Use of a drug in a manner that is not consistent with its labeling is extralabel use.⁷

We found you administered Sulfadimethoxine Injection 40% ((b)(4)) in an extralabel manner to a dairy cow with ear tag (b)(4). Your veterinarian’s prescription labeling and the Sulfadimethoxine Injection 40% label read 25 mg/lb for initial dose and 12.5 mg/lb for maintenance doses. According to a statement made by Shane Stangl and your treatment records, cow (b)(4) was treated with (b)(4) of sulfadimethoxine on (b)(4) of sulfadimethoxine from (b)(4), and (b)(4) of sulfadimethoxine from (b)(4). Accordingly, you failed to follow the labeled doses and your veterinary prescription for the maintenance treatments on (b)(4). Further, you estimated cow with ear tag (b)(4) weighed (b)(4) pounds at the time of treatment; however, the (b)(4) dosage given on (b)(4) would be for a cow weighing 960 pounds. Additionally, you administered sulfadimethoxine to cows with ear tag numbers (b)(4) in an extralabel manner by administering the initial dose for (b)(4).⁸ Extralabel use of sulfonamide drugs in lactating dairy cattle is prohibited, except approved uses of sulfadimethoxine.⁹

Furthermore, our inspection found you used (b)(4) (flunixin meglumine (b)(4)) in an extralabel manner by not using as directed by its approved labeling and your veterinary prescription. You treated cow with ear tag (b)(4) with flunixin meglumine for (b)(4) from (b)(4). The manufacturer’s labeling and your veterinary prescription label indicate treatments can be given (b)(4).¹⁰

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act¹¹ and 21 CFR Part 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. Because your extralabel uses of these drugs were not in compliance with Title 21, Code of Federal Regulations (CFR), part 530 (21 CFR 530), you caused the drugs to be unsafe and adulterated.¹² The doing of any act to a drug after shipment of the drug and/or its components in interstate commerce and while the drug is held for sale (whether or not the first sale) that results in the article being adulterated or misbranded is prohibited.¹³

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.

We have the following comments:

Your administration of drugs does not always appear to use animal weights consistently for dosing purposes. For example, on (b)(4), you administered an initial dose of (b)(4) of sulfadimethoxine to cow (b)(4). This would be the correct dose for a cow weighing approximately 960-pounds. The subsequent doses of sulfadimethoxine administered to this animal on (b)(4) were listed as (b)(4), which would be equivalent dose for a 1,280-pound cow. Also, on (b)(4), you administered (b)(4) of flunixin meglumine to the same cow, cow (b)(4). This would be the correct dose for a 1500-pound cow if given at a rate of 2 mL per 100 pounds, according to the label.

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 Rabe at Stephen.rabe@fda.hhs.gov 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
Sandy Larson
Minnesota Department of Agriculture
Dairy and Meat Inspection
Sandra.larson@state.mn.us

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

_______________________

1 Allendale Dairy’s ear tag 130 corresponds to the cow sold at auction with backtag 41LO3231.

2 See 21 CFR 556.640(b)(2)(i)

3 See section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)].

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

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

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

7 See 21 CFR 530.3(a).

8 See 21 CFR 522.2220(d)(4)(i) for the indications for use in cattle.

9 See 21 CFR 530.41(a)(9).

10 See21 CFR 522.970(e)(2)(i)(A) for the indications for use in cattle.

11 21 U.S.C. § 360b(a)(4) and (5).

12 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].

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