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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ada Veterinary Clinic, Inc. 09-Sep-05

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

Public Health Service
Food and Drug Administration
  Minneapolis District Office
Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145




September 9, 2005

Ref: 2005-DAL-WL-29

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Dr. Donald D. Connally, DVM,
President
Ada Veterinary Clinic, Inc.
P.O. Box 1445
Ada, Oklahoma 74820

Dear Dr. Connally:

This letter follows an inspection of your veterinary -practice located in Ada, Oklahoma at 1020 Sandy Creek Dr., by Food and Drug Administration investigators on May 5 & 10, 2005, and addresses actions in your veterinary practice, and the potential for public health concerns. The investigation revealed that you dispensed the drug sulfadimethoxine to Mr. [redacted] and that your actions caused an illegal tissue residue in this animal, which was offered for sale for slaughter as food.

On February 14, 2005, you prescribed and sold 5 Albon-SR (sulfadimethoxine) 12.5g boluses to Mr. [redacted] for treatment of a cow to prevent gut infection without providing [redacted] information about the required drug withdrawal period of at least 21days. This withdrawal period is necessary t ensure violative drug residues do not occur in edible tissues of food animals. [redacted] treated the animal as prescribed verbally by you on that same day.

On or about February 24, 2005 [redacted] delivered the medicated animal, a black cow, to the [redacted], for sale for slaughter as human food. The cow was purchased by a buyer on the same date and was offered for slaughtered as human food on February 25, 2005, at [redacted] USDA analysis (Laboratory Report #450467) of tissue samples collected from the animal identified the presence of 1.25 parts-per-million (ppm) and 1.13 ppm of Sulfadimethoxine in the liver and muscle tissues, respectively. A tolerance level of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle (Title 21, Code of Federal Regulations , Section 556.640). The presence of sulfadimethoxine at levels above the established tolerance in the edible tissues of the anima! 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)].

The above is not intended to be an all-inclusive list of violations. As a veterinarian, you are responsible for ensuring that your actions do not cause illegal drug residues in edible animal tissues. 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 within 15 working days of the steps you have taken to bring your veterinary practice into compliance with the law. Your response should include each step taken, or to 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 any copies of available documentation demonstrating corrections have been made.

Your response should be addressed to the attention of James R. Lahar, Compliance Officer at the above letterhead address.

Sincerely yours,
/s/

Michael A. Chappell
Dallas District Director