Thompson Feedlot & Farms 6/26/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000FAX: 303-236-3100
June 26, 2013
Thomas H. Thompson III, Owner
Thompson Feedlot and Farms
9250 Rector Leader Mile Road
Byers, Colorado 80103
Ref. #: DEN-13-17-WL
Dear Mr. Thompson:
On February 14, 15, and 20, and March 22, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle and sheep feedlot operation located at 9250 Rector Leader Mile Road, Byers, Colorado. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. 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
Our investigation revealed that you adulterated the new animal drug (b)(4) (sulfadimethoxine) Injection - (b)(4). Specifically, our investigation revealed that you did not use (b)(4) (sulfadimethoxine) Injection - (b)(4), as directed by its approved labeling. Use of this drug in this manner is an extralabel use as defined under Title 21, Code of Federal Regulations, Section 530.3(a) (21 C.F.R. 530.3(a)). A copy of 21 C.F.R. Part 530 is attached for your reference.
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 you administered the drug, (b)(4) (sulfadimethoxine) Injection - (b)(4), to your sheep without following the directions for the species of animal as stated in the approved labeling. Your extralabel use of the drug, (b)(4) (sulfadimethoxine) Injection - (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. 530, you cause the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.
We acknowledge receipt of your undated letter in response to our Form FDA483, Inspectional Observations, issued on March 22, 2013, and amended on April 5, 2013. Because your response does not give sufficient detail for the steps that are necessary in bringing your firm into compliance with the FD&C Act and its implementing regulations, we find your response to be inadequate.
You should take prompt action to correct the above violations and to establish procedures whereby such 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, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any documentation demonstrating that corrections have been made.
Your response should be sent to U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087, Attention: Thomas R. Berry, PharmD., Compliance Officer. If you have any questions about this letter, please contact Dr. Berry at (303) 236-3028.
LaTonya M. Mitchell
Ronald K. Jones, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, Colorado 80225
John Salazar, Commissioner
Colorado Department of Agriculture
700 Kipling Street, Suite 4000
Lakewood, Colorado 80215