WARNING LETTER

Golden Dakota Farms LLC MARCS-CMS 725317 — May 20, 2026

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 (b)(4).
You do not maintain complete treatment records. You administered (b)(4) to a dairy cow with ear tag (b)(4) from (b)(4), without documenting the dosage in your treatment records. The cow was sold on (b)(4), and was later found to contain a violative ampicillin residue in muscle tissue and kidney tissue at the time of slaughter on (b)(4).

Food held under insanitary conditions whereby it may have been rendered injurious to health is adulterated.⁴ The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.⁵

Adulteration of a New Animal Drug

Our inspection found that you did not use (b)(4), as directed by the drug manufacturer’s approved labeling and your veterinarian’s prescription labels. Use of a drug in a manner that is not consistent with its labeling is an extralabel use.⁶

Our inspection found you administered (b)(4) concentration to treat a dairy cow with ear tag (b)(4) from (b)(4), for a difficult birth or “HARDPUL” without consulting your veterinarian. Your veterinarian’s prescription labeling and Basic Treatment Protocols for (b)(4) permit (b)(4) doses at (b)(4). Your veterinarian estimated that the cow with ear tag (b)(4) weighed approximately (b)(4) at the time of slaughter. The dose for the cow should have been at most (b)(4), but the dose you administered was (b)(4). You overdosed cow with ear tag (b)(4) with (b)(4). You, therefore, did not follow the labeled dose and used an approved animal drug in an extralabel manner without the supervision of a licensed veterinarian, in violation of Title 21, Code of Federal Regulation 530.11(a) (21 CFR 530.11(a)). 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 (VCPR).^{7, 8}

Because your use of drugs was not in conformance with approved labeling and did not comply with 21 CFR 530, you caused the drugs to be unsafe and adulterated.⁹ The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.¹⁰

Evaluation of Your Response

In your written response, dated February 11, 2026, you provide a root cause investigation dated June 12, 2025, conducted by your veterinarian, into the violative drug residue found in the dairy cow with the ear tag (b)(4) and an outline of steps you are planning to take to reduce the likelihood of recurrence.

Your proposed corrections include using a weigh tape to determine animal weights before treatment, trending animal weights from scale tickets, limiting individuals responsible for administering treatments to animals, and reviewing withhold times before sales from the farm. However, we are not able to fully evaluate your response because you did not provide supporting documentation in your written response to demonstrate these corrections are consistently implemented.

Additionally, as to the violative drug residue found in the dairy cow with ear tag (b)(4), your response states that a withhold time was not observed on the cow card. This is not enough information to determine the possible cause of this violative drug residue to reduce the likelihood of recurrence.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. 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 an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal action, including without limitation, seizure, and injunction.

We also have the following comment.

When medicating an animal with a drug, the dose administered to the animal must be based on that animal’s weight to ensure that animal receives the appropriate dosage based on the drug manufacturer’s directions and/or your veterinarian’s prescription. Additionally, we encourage you to work with your veterinarian to ensure that any treatment protocols or other documents, whether paper or electronic, that have medicating directions follow the drug manufacturer’s directions and/or your veterinarian’s prescription. Not following that manufacturer’s labeled directions or your veterinarian’s prescription could lead to extralabel use and may potentially lead to a residue in the animal’s tissues.

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 actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe your products are not in violation of 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 Andrew J. Howard at Andrew.Howard@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Andrew J. Howard by telephone at (410) 779-5125, or by the above email address.

/S/

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

cc:
Nicholas Coetzee, Owner
Golden Dakota Farms LLC
(b)(6), (b)(7)(C)

(b)(4), (b)(6), (b)(7)(C)

Janet McGinn, Director
Food and Drug Administration
Human Food Program
Office of Dairy and Seafood Safety
Division of Dairy Safety

____________________

1 See Title 21, Code of Federal Regulations, 556.40(b) (21 CFR 556.40(b)).

2 See Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(2)(C)(ii)].

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

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

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

6 See 21 CFR 530.3(a).

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

8 See 21 CFR 530.3(i).

9 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].

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