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April 14, 2020

CMS Case #604555

WARNING LETTER

Dear Mrs. De Boer,

On December 9, 2019, and January 9, 2020, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at Private Road 116, Box 7573, Winnsboro, TX. Our investigation 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 example, you failed to maintain adequate treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), because it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

We also found that you adulterated the animal drugs penicillin G procaine and flunixin meglumine. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as defined under Title 21 Code of Federal Regulations (C.F.R.), Section 530.3(a) (21 C.F.R. 530.3(a)).

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 Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. 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.

Our investigation found that on April 12, 2019, and April 13, 2019, you administered 40 ml of penicillin G procaine to a dairy cow with backtag #(b)(4), ear tag #(b)(4), and metal silver tag #(b)(4) without following the drug's label. You administered 40 ml penicillin G procaine IM whereas the approved dosage is approximately (b)(4) ml for this animal. Additionally, the label states that (b)(4). Further, you treated this animal for lameness, which is no an approved indication or use of penicillin G procaine.

Our investigation also revealed that you administered flunixin meglumine to this cow without following the drug's label. In particular, you administered 20 ml flunixin meglumine, whereas the approved dosage is approximately (b)(4) mI for this animal. Further, you treated this animal for lameness, which is not an approved indication for use for flunixin meglumine.

Your extralabel use of penicillin G procaine and flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. § 351 (a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

In addition to the above violations, on May 13, 2019, you were notified by USDA/FSIS that you sold a cow with the backtag #(b)(4), ear tag #(b)(4), and metal silver tag #(b)(4) that had residues of penicillin and flunixin above the established tolerance for these drugs. As a producer, it is imperative that you ensure that medication is used in accordance with the label or veterinary prescription and that records are maintained and reviewed prior to shipment in order to prevent unsafe drug residues.

Your written response should be sent to Rene R. Ramirez, Compliance Officer, U.S. Food and Drug Administration , 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Mr. Ramirez at 210-308-1425 or rene.ramirez@fda.hhs.gov.

Sincerely,
/S/

Edmundo Garcia, Jr.
District Director I FDA Dallas District
Program Division Director
Office of Human and Animal Food
Operations - West Division 3

 

cc: FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598

Lori Woznicki, Food and Drug Inspections Branch
Manager, Division of Regulatory Services
Texas Department of State Health Services
1100 W. 49th Street
Austin, TX 78756