John Brasil Dairy 8/22/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700FAX: 510-337-6701
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
August 22, 2013
John H. Brasil, Owner
John A. Brasil, Manager
John Brasil Dairy
2613 South Mitchell Road
Turlock, California 95380-9340
Dear Messrs. Brasil:
On July 3, 9, and 11, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2613 South Mitchell Road, Turlock, California. 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 drugs (b)(4) (ceftiofur hydrochloride), (b)(4) (oxytetracycline hydrochloride), (b)(4) and (b)(4) Oxytocin, (b)(4). Specifically, our investigation revealed that you did not use (b)(4), Oxytetracycline Hydrochloride, and Oxytocin as directed by their prescription label or approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (21 C.F.R. 530.3(a)). We have enclosed a copy 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 (b)(4) to a bob veal calf without following the directions for the class of animal as stated in your servicing veterinarian’s prescription. Our investigation also found that you administered (b)(4) to your dairy cows without following the route of administration as stated in your servicing veterinarian’s prescription. (b)(4) is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13).
Our investigation found that you administered (b)(4) to your dairy cows without following the route of administration, duration of treatment, and slaughter and milk withholding times as stated in your servicing veterinarian’s prescription. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
Our investigation also found that you administered Oxytocin to your dairy cows without following the dosage and duration of treatment as stated in your servicing veterinarian’s prescription. Your extralabel use of Oxytocin 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.
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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.
Kathleen M. Lewis, J.D.
San Francisco District
U. S. Food and Drug Administration