Department of Health and Human Services
Public Health Service
Food and Drug Administration
San Francisco District
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3004596345
April 23, 2012
Ramiro M. Ferreira, Co-owner
Mary L. Ferreira, Co-owner
Ferreira and Son Dairy
11953 Tyler Road Red Bluff,
Dear Mr. and Mrs. Ferreira:
On March 14, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 11953 Tyler Road, Red Bluff, 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 drug (b)(4) (flunixin meglumine injectable solution), (b)(4) . Specifically, our investigation revealed that you did not use (b)(4) (flunixin meglumine injectable solution), (b)(4) , as prescribed by your servicing veterinarian and 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.), 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) (flunixin meglumine injectable solution), (b)(4) , to one of your bob veal calves, without following the animal class and indications for use as prescribed by your servicing veterinarian and as directed by its approved labeling. Our investigation also found that you administered (b)(4) (flunixin meglumine injectable solution), (b)(4) , to your dairy cows without following the route of administration as prescribed by your servicing veterinarian and as directed by its approved labeling. Your extralabel use of (b)(4) (flunixin meglumine injectable solution), (b)(4) , 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 your servicing veterinarian's prescription or the 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 Lawton 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 .
Barbara J. Cassens
San Francisco District