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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Arizona Dairy Company, LLP 09-Aug-07

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, CA 92612-2606

Telephone (949) 608-2900


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 9, 2007

W/L 15-07

Ross A. Tappan
General Manager
Arizona Dairy Company, LLP
19135 East Elliot Road
Mesa, Arizona 85212

Dear Mr. Tappan:

An investigation of your dairy operation located at 19135 East Elliot Road, Mesa, Arizona conducted by a representative of the United States Food and Drug Administration (FDA) on May 2 and 3, 2007, confirmed that you offered 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 inspection also revealed that you caused the new animal drugs, flunixin meglumine and penicillin G procaine, 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 web page at www.fda.gov.

On or about November 1, 2006, you sold a culled dairy cow identified with ear tag #66579 for slaughter as human food [redacted] to a broker/hauler. On or out November 2, 2006, this animal was slaughtered at [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 at 0.64 parts per million (ppm) in the kidney, 0.08 ppm in the liver, and 1.08 ppm in the muscle tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.510 (21 C.F.R. 556.510). Additionally, USDA/FSIS analysis identified the presence of flunixin at 3.70 ppm in the liver. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver tissue of cattle as codified in 21 C.F.R. 556.286. The presence of these drugs in the edible tissues from 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)].

On or about January 11, 2007, you sold a culled dairy cow identified with ear tag #59481 for slaughter as human food to a [redacted] broker/hauler. On or about January 12, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of flunixin at 0.235 ppm in the liver. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver tissue of cattle as codified in 21 C.F.R. 556.286. The presence of this drug in the edible tissues from 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)].

On or about February 14, 2007, you sold a culled dairy cow identified with ear tag #61690 for slaughter as human food to [redacted] a broker/hauler. On or about February 15, 2007, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine: at 0.17 ppm in the liver, and 0.14 ppm in the muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in 21 C.F.R. 556.640. Additionally, USDA/FSIS analysis identified the presence of flunixin at 0.14 ppm in the liver and 0.083 ppm in the muscle tissue. A tolerance of 0.125 ppm and 0.025 ppm has been established for residues of flunixin in the liver and muscle tissue of cattle, respectively, as codified in 21 C.F.R. 556.286. The presence of these drugs in the edible tissues from 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)].

Our investigation also found that you hold animals under conditions whereby medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, 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, and 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 penicillin G procaine and flunixin meglumine 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 USC 360b(a)(4)] and 512(a)(5) [21 USC 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of penicillin G procaine and flunixin meglumine failed to comply with these requirements.

For example, you administered the drug, flunixin meglumine, without following the approved withdrawal time and you administered the drugs, penicillin G procaine and flunixin meglumine, without following the duration of treatment set forth in the approved labeling. 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 illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. 360b(a) ]of the Act, and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. 301(a)(5)] of the Act.

The above is not intended to be an all-inclusive list of violations. As a producer of animals, which are 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 assure that the procedures you have established will prevent their recurrence. Failure to do so may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your dairy into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. Please include copies of any available documentation demonstrating that corrections have been made. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which such corrections will be made. If you have any questions or need clarifications regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.

Your written response should be directed to:

Pamela B. Schweikert
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612

Sincerely,

/S/

Alonza E. Cruse
District Director

CC:
Dairy Veterinary Services
501 West Ray Road
Chandler, Arizona 85225

Arizona Department of Agriculture
1688 West Adams Street
Phoenix, Arizona 85007-2617

Julie A. Cornett D.V.M.
Senior Veterinary Officer
Technical Assistance/Correlation
USDA/FSIS
Technical Service Center
1299 Farnam Street
Omaha, Nebraska 68102