| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesUNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3008813145
WARNING LETTER
October 26, 2011
Lorraine F. Silveira, Co-Owner
Anthony F. Silveira, Co-Owner
Silveira Ranches
9501 Redwood Highway
Novato, California 94945
Dear Mrs. & Mr. Silveira:
On August 9, 11, and 17, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 9501 Redwood Highway, Novato, 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.
Our investigation found that you adulterated the new animal drugs sulfadimethoxine (b)(4), penicillin G procaine (b)(4), florfenicol (b)(4), cephapirin sodium (b)(4), and neomycin-penicillin G procaine (b)(4) Mastitis Tubes containing Neomycin, (b)(4), and Penicillin G Procaine, (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs 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). 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 sulfadimethoxine (b)(4) to one of your lactating dairy cows identified with ear tag (b)(4) without following the dosage as stated in the approved labeling. Your use of sulfadimethoxine in this manner is an extralabel use. The extralabel use of sulfadimethoxine in lactating dairy cattle is prohibited in accordance with 21 C.F.R. 530.41(a)(9).
Our investigation also found that you administered penicillin G procaine (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the dosage as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
We found that you administered florfenicol (b)(4) to several of your replacement calves more frequently than prescribed by your veterinarian. Your extralabel use of florfenicol was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
Also, you administered cephapirin sodium (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the directions for consecutive treatments as stated in the approved labeling. Your extralabel use of cephapirin sodium was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
In addition, you administered (b)(4) Mastitis Tubes (containing Neomycin (b)(4), and Penicillin G Procaine (b)(4)) to one of your dairy cows identified with ear tag (b)(4) without following your veterinarian’s directions for consecutive treatments. Your extralabel use of (b)(4) Mastitis Tubes 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 Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov.
Sincerely,
/s/
Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration
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