Inspections, Compliance, Enforcement, and Criminal Investigations
Lakeview Dairy Farms 05-May-08
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 3004794840
May 5, 2008
John A. Schoneveld, Co-Owner
Jolene Schoneveld, Co-Owner
Lakeview Dairy Farms
1510 Cromerton Place
Bakersfield, California 93311
Martin Bouma, Co-Owner
Alice Bouma, Co-Owner
1311 Monticello Court
Ontario, California 91762
Dear Mr. and Mrs. Schoneveld and Mr. and Mrs. Bouma:
An inspection of your dairy operation located at 17702 Bear Mountain Boulevard, Bakersfield, California, conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 29 and February 11, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and 21 U.S.C. § 342(a)(4)]. The inspection also revealed that you caused the new animal drug [redacted] (Flunixin Meglumine) Injectable Solution to become unsafe within the meaning of section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated within the meaning of section 501 (a)(5) of the Act [21 U.S.C. § 351 (a)(5)). 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 July 23, 2007, you consigned a dairy cow, identified by back tag number [redacted] through [redacted]. This cow was sold through the auction for slaughter as food to [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected (USDA/FSIS Form No. [redacted] from that animal identified the presence of flunixin in the liver tissue at 0.448 parts per million (ppm) and in the muscle tissue at 0.063 ppm. A tolerance of 0.125 ppm in the: liver and of 0.025 ppm in the muscle of cattle has been established for residues of Bunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286). The presence of this drug in these amounts in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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. 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 complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
In addition, you adulterated [redacted] (Flunixin Meglumine) Injectable Solution within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the extralabel use complies with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. § 360b(a)(4) and 21 U.S.C. § 360b(a)(5)], and 21 C.F.R. Part 530; including that the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Our investigation found that your extralabel use of [redacted] (Flunixin Meglumine) Injectable Solution failed to comply with these requirements. For example, you administered [redacted] to a dairy cow via intramuscular injection instead of following your veterinarian's label directions, which specified an intravenous mute of administration, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, 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) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the 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 specified in this letter 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 specified 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 frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrective actions have been made.
Your written response should be sent to Karen L. Robles, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Ms. Karen Robles at (916) 930-3674, Ext. 114.
Barbara J. Cassens
San Francisco District
Asif Mann, Branch Chief
California Department of Food and Agriculture
Livestock Drugs and Egg Regulatory Services Branch
1220 N Street
Sacramento, California 95814-5607
Neal Westgerdes, D.V.M.
United States Department of Agriculture
Food Safety & Inspection Service
620 Central Avenue Building C
Alameda, California 94501