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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, MI 48207
July 3, 2014
Tom A. I. De Vos, Member
Double D Dairy, LLC
5731 North Winn Road
Weidman, Michigan 48893
Dear Mr. De Vos:
On February 21, March 24, and April 3, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5731 North Winn Road, Weidman, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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
We found that you adulterated the new animal drugs Naxcel (ceftiofur sterile powder) NADA 140-338) and Vetrimycin 100 (oxytetracycline hydrochloride injection) ANADA 200-452. Specifically, our investigation revealed that you did not use Naxcel and Vetrimycin 100 as directed by their approved labeling and/or your servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. 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 you administered Naxcel to your dairy cows without following the duration of treatment as stated in the approved labeling. Naxcel is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13). In addition, our investigation found that you administered Vetrimycin 100 to your lactating dairy cows without following the route of administration, animal class, and duration of treatment as stated in the approved labeling. Your extralabel use of Vetrimycin 100 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 their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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.
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.
We acknowledge receipt of your written response dated April 14, 2014, regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that the label directions will be followed for ceftiofur and if the animal has not completely recovered, it will be reevaluated and a different treatment regimen will be followed. You also stated you will no longer use oxytetracycline on the farm. We can only determine the effectiveness of your corrective actions over time.
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 LCDR Kelli Wilkinson, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact LCDR Wilkinson at 313-393-8120.
Acting District Director
Detroit District Office