Braaksma Partnership 12/11/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
December 11, 2012
In reply refer to Warning Letter SEA 13-07
Gregory L. Braaksma, Partner
Douglas F. Braaksma, Partner
Richard V. Braaksma, Partner
Darren Braaksma, Partner
Robert Braaksma, Partner
Braaksma Partnership, dba B-3 Dairy
7450 Amsterdam Road
Manhattan, Montana 59741
Dear Messrs. Braaksma:
On October 16-18, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6701 Dyk Road, Manhattan, Montana. 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
We found that you adulterated the new animal drug SUPRA SULFA III (sulfamethazine) NADA 120-615. Specifically, our investigation revealed that you did not use sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.) 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 sulfamethazine to a lactating dairy cow with ear tag # (b)(4) without following the animal class as stated in the approved label. Sulfamethazine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9). 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).
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 Mark L. Collins, Acting Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Acting Compliance Officer Mark L. Collins at 425-302-0420.
Charles M. Breen
cc: Ron de Yong, Director
Montana State Department of Agriculture
302 North Roberts
Helena, Montana 59601