Inspections, Compliance, Enforcement, and Criminal Investigations
Golden View LP 26-Sep-07
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
September 26, 2007
Bryan Vander Dussen, Partner
Golden View LP
10573 East Edison Avenue
Ontario, California 91761-8406
Dear Mr. Vander Dussen:
An investigation of your dairy operation located at 10573 East Edison Avenue, Ontario, California conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 16, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug, Banamine (Flunixin Meglumine) Injectable Solution (NADA 101-479) to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 [21 U.S.C. 360b] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about September 20, 2006, you sold a dairy cow with Back Tag 9135 for slaughter as food to [redacted]. On or about September 20, 2006, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSLS) analysis of tissue samples collected from that animal identified the presence of flunixin in the liver at 0.852 parts per million (ppm). A tolerance of 125 parts per billion (or 0.125 ppm) has been established for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 C.F.R. 556.286). The presence of this amount of this drug in the liver of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] of the Act.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain adequate treatment records to assure that appropriate withdrawal times have been observed. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Act.
In addition, you adulterated Banamine (Flunixin Meglumine) Injectable Solution (NADA 101479) within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of the drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. 360b(a)(4)] and 512(a)(5) [21 U.S.C. 360b(a)(5)J of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Banamine (Flunixin Meglumine) Injectable Solution (NADA 101-479) failed to comply with these requirements. For example, you administered Banamine (Flunixin Meglumine) Injectable Solution (NADA 101-479) without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in a drug residue above the established tolerance for flunixin in the liver of cattle, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act, and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act.
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 above violations and to establish procedures whereby such 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, state the reason for the delay and the time within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please direct your written response to the attention of
Pamela B. Schweikert
Director, Compliance Branch
United States Food and Drug Administration
Los Angeles, CA 92612-2506
If you have any questions about the content of this letter please contact Compliance Officer Barbara Rincon at (949) 608-4439.
Alonza E. Cruse
Los Angeles District
Isabel Arrington, D.V.M.
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102
Dennis Thompson, Branch Chief
Meat and Poultry Inspection
California Department of Food and Agriculture
1220 "N' Street, Room A-125
Sacramento, California 95814
Bradford Scott, D.V.M.