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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

J & D Wilson & Sons Dairy 05-Mar-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


 

 


 

VIA FEDERAL EXPRESS

Our Reference: 3005404216
 

March 5, 2007

James L. Wilson, Managing Partner
Cornelius A. Vanderham, Partner
J & D Wilson & Sons Dairy
11720 West Mount Whitney
Riverdale, California 93656
 

WARNING LETTER
 

Dear Messrs. Wilson and Vanderhan:

An investigation of your dairy operation located it 11720 West Mount Whitney, Riverdale, California, conducted by representatives of the U.S. Food & Drug Administration (FDA) on November 21 and 28, 2005, confirmed that you offered two animals for sale for slaughter as food that were 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 investigation also revealed that you caused the new animal drugs flunixin meglumine [redacted] and penicillin-dihydrostreptomycin ([redacted]) to become unsafe within the meaning of section 512[21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. §351(a)(5)] of the Act. You can find the Act and its associated regulations on the internet through links on the FDA's webpage at www.fda.gov.

On or about April 5 2006, you consigned a dairy cow (ear tag # [redacted], identified with back tag number [redacted], to [redacted] in Fresno, California. On April 5, 2006, this cow was slaughtered by [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of flunixin in the liver at 0.87 parts per million (ppm). A tolerance level for residues of flunixin has been established for the liver of cattle at 0.125 ppm as codified in Title 21, Code of Federal Regulations, Part 556.286(2l C.F.R., 556.286). The presence of this drug in the liver of this dairy cow in this amount 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.

On or about July 17, 2006, you consigned another dairy cow (ear tag # [redacted]), identified with back tag number [redacted] to [redacted], in Fresno, California. On July 17, 2006, this cow was slaughtered by [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney at 0.36 parts per million (ppm). A tolerance level for residues of penicillin has been established for uncooked edible tissues of cattle at 0.05 ppm as codified in Title 21, Code of Federal Regulations, Part 556.510 (21 C.F.R. 556.510). The presence of this drug in the kidney of this dairy cow in this amount 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 complete treatment records that contain the amount of the drug you used, the route it was administered and the withdrawal time for meat and milk. You also lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 the drug flunixin meglumine [redacted] 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 a 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)] of the Act and 21 C.F.R Part 530. Our investigation found that your extralabel use of flunixin meglumine failed to comply with these requirements. For example, you administered flunixin meglumine [redacted] without following your veterinarian's written instructions for route of administration and type of animal, in violation of 21 C.F.R. 530.10(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 5l2(a) [21 U.S.C. § 360b(a)] 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.

In addition, our investigation found that you adulterated the drug penicillin-dihydrostreptomycin [redacted] 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. For example, you administered penicillin-dihydrostreptomycin [redacted] without following the withdrawal period set forth in your veterinarian's written instructions, in violation of 21 C.F.R. 530.10(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) [2l U.S.C. § 360b(a)] 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.
 

We note that on December 18, 2006. USDA/FSIS notified you of an additional illegal tissue residue in a dairy cow originating from your dairy. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of flunixin in the liver at 0.140 parts per million (ppm).

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 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 directed to Karen L. Robes, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. lf you have any questions regarding this letter, please contact Karen Robles at (916) 930-3674 ext 14.
 

Sincerely,

/S/
 

Barbara J. Cassens
District Director
San Francisco District