De Groot Sheep Inc 5/24/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
May 24, 2012
RETURN RECEIPT REQUESTED
Ref. – KAN 2012-7
Mr. Steven P. De Groot
President and Owner
De Groot Sheep Inc.
3824 390th Street
Orange City, Iowa 51041-7542
Dear Mr. De Groot:
On March 14, 15, and 16, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your sheep operation located at 3824 390th
Street, Orange City, Iowa. 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 found that you adulterated the new animal drug fenbendazole that was contained in a customized medicated feed ration fed to your lambs. Specifically, our investigation revealed that you did not use a Type C Medicated Feed containing SAFE-GUARD .5% (fenbendazole) (Swine\Beef\Dairy\Horse Dewormer) in accordance with the drug approval for fenbendazole. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, 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 you administered the new animal drug fenbendazole without following the animal species as stated in the approved labeling. Your extralabel use of fenbendazole 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. Part 530, you caused 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).
In addition, you adulterated SAFE-GUARD .5% (fenbendazole) Type B Medicated Feed (Swine\Beef\Dairy\Horse Dewormer) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use this medicated feed in conformance with its approved labeling.
Your use of this medicated feed without following the animal species as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
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.
Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 11630 W 80th Street, Lenexa Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-752-2774.
Acting District Director
Kansas City District
cc: Kevin E. Klommhaus, Bureau Chief
Feed & Fertilizer Bureau
Iowa Department of Agriculture & Land Stewardship
502 East 9th Street
Des Moines, Iowa 50319