Public Health Service Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
UNITED PARCEL SERVICE DELIVERY SIGNATURE REQUESTED
December 29, 2015
Joshua S. Fernandes, Managing Partner
Greg W. Fernandes, Managing Partner
Garry A. Fernandes, Managing Partner
Jared R. Fernandes, Managing Partner
Frank J. Fernandes, Managing Partner
Legacy Ranch #2
23135 Road 148
Tulare, California 93274-9647
Dear Messrs Fernandes:
On September 30 and October 08, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, Legacy Ranch #2, located at 8660 Avenue 96, Pixley, California 93256. 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) (sterile penicillin G procaine, injectable suspension, (b)(4). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling and/or by a veterinarian’s prescription. Use of this drug in this manner is an extralabel use. See 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 also found that you administered (b)(4) (sterile penicillin G procaine, injectable suspension, (b)(4) to your dairy cows without following the dosage per injection site and withdrawal period prior to slaughter as stated in your veterinarian’s label directions for use. Your extralabel use of the (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 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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 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 Ext. 1114 or by e-mail at email@example.com.