Inspections, Compliance, Enforcement, and Criminal Investigations
Gonsalves Ranch 12/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3009533106
December 7, 2012
Joseph A. Gonsalves, Partner
Deborah M. Gonsalves, Partner
Michael J. Gonsalves, Partner
Joseph A. (Joey) Gonsalves, Partner
7237 Maze Boulevard
Modesto, California 95358
Dear Messrs. Gonsalves and Mrs. Gonsalves:
On October 10, 17, and 19, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cattle ranch located at 7237 Maze Boulevard, Modesto, 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 offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about March 23, 2012, you sold an Angus black baldy heifer calf, identified with back tag (b)(4), for slaughter as food. On or about March 23, 2012, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 0.192 parts per million (ppm) in the muscle tissue and tulathromycin in the kidney tissue. FDA has established a tolerance of 0.1 ppm in the uncooked edible tissues of cattle for residues of sulfadimethoxine as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). FDA has not established a tolerance for residues of tulathromycin in the kidney tissue of cattle. The presence of these drugs in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We found that you adulterated the new animal drugs (b)(4) (cephapirin sodium) (b)(4) and (b)(4) (cephapirin benzathine) (b)(4). Specifically, our investigation revealed that you did not use cephapirin sodium and cephapirin benzathine as directed by their approved labeling. Use of these drugs 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 found that you administered cephapirin sodium and cephapirin benzathine to your cattle without following the animal class, dosage, route of administration, and conditions for use as directed by its approved labeling. Your extralabel use of cephapirin sodium and cephapirin benzathine 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 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 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.
Barbara J. Cassens
San Francisco District
U. S. Food and Drug Administration