Tex-Stein Dairy

WARNING LETTER Tex-Stein Dairy MARCS-CMS 728755 — June 16, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL NO HARD COPY TO FOLLOW Product: Animal & Veterinary Drugs Recipient: Recipient Name Chad L. Steinberger Recipient Title Owner Tex-Stein Dairy 257 Munchrath Road Windthorst , TX 76389 United States chadsteinberger@(b)(6), (b)(7)(C) Issuing Office: Center for Veterinary Medicine United States WARNING LETTER CMS # 728755 June 16, 2026 Dear Chad Steinberger, The U.S. Food and Drug Administration (FDA) conducted a for-cause inspection of your dairy farm located at 257 Munchrath Road, Windthorst, Texas from February 5 through 19, 2026. This letter notifies you of the significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection of your dairy operation. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. However, you have not responded to the Form 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 Our inspection found you offered for sale a lactating dairy cow for slaughter as food that was adulterated. Specifically, on (b)(4) , you sold a lactating dairy cow identified with ear tag (b)(4) . This animal was subsequently slaughtered the same day at (b)(4) in (b)(4) . The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this cow identified the presence of meloxicam in kidney tissue. FDA has not established a tolerance for meloxicam in the edible tissues of food-producing animals. In addition, USDA/FSIS analysis identified the presence of desfuroylceftiofur (an analyte of ceftiofur drugs) at 5.41 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 0.4 ppm of desfuroylceftiofur in the kidneys of cattle. 1 The presence of these drugs in the edible tissues of this animal at these levels cause the food to be adulterated. A food is deemed to be 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 any established safe levels. 3 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act. 4 Additionally, our inspection 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 treatment records for drugs administered to cattle on your farm. For example, your drug treatment record on June 6, 2025, for the cow with ear tag (b)(4) did not document the following for (b)(4) and meloxicam: the route of administration, reason for treatment, and withdrawal time. Additionally, for meloxicam you did not document the dosage in your treatment records. Further, you lack an adequate system to account for the drugs held for use in treating your food-producing animals. For example, you did not maintain an inventory of the drugs you use to treat your animals. Food held under conditions whereby it may have been rendered injurious to health is adulterated. 5 Adulteration of a New Animal Drug Our inspection found you used meloxicam contrary to the prescription from your veterinarian. Use of a drug in a manner that is not consistent with its labeling and contrary to the prescription from your veterinarian is illegal extralabel use. 6 Our investigation found that you administered meloxicam to a dairy cow with ear tag (b)(4) and shipped the animal for slaughter 20 days after treatment. Specifically, you did not follow the 21-day post-treatment meat withdrawal time on your veterinarian’s meloxicam prescription. Your extralabel use of meloxicam was not under the supervision of a licensed veterinarian and resulted in USDA/FSIS detecting the presence of meloxicam in the kidney tissue of dairy cow (b)(4) , in violation of 21 CFR 530.11(a) and (c). As indicated above, FDA has not established a tolerance for meloxicam in the edible tissues of food-producing animals. Because your use of meloxicam was not in conformance with your veterinarian’s prescription labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe and adulterated. 7 The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. 8 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 any violation may lead to regulatory, or where appropriate, legal action. Within 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 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 FDA, CVM, 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 Allison C. Hunter at allison.hunter@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Allison C. Hunter by telephone at (513) 322-0629, or by email at allison.hunter@fda.hhs.gov. /S/ Isaac K. Carney Director of Food Compliance, Office of Surveillance and Compliance Center for Veterinary Medicine U.S. Food and Drug Administration Cc: Janet McGinn, DVM Director, Division of Dairy Safety Office of Dairy and Seafood Safety Human Foods Program janet.mcginn@fda.hhs.gov Keelan Yoder, DVM Salt Creek Veterinary Hospital 759 State Highway 114E Olney, Texas 76374-6206 (b)(6), (b)(7)(C) _________________________ 1 See 21 CFR 556.113(b)(1)(i). 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 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. 5 See Section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)]. 6 See 21 CFR 530.3(a). 7 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]. 8 See Section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Content current as of: 08/10/2026 Regulated Product(s) Animal & Veterinary Drugs