Caldwell Animal Hospital 12/3/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
December 3, 2013
WARNING LETTER NO. 2014-NOL-05
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Holley G. Caldwell, D.V.M., Owner
Caldwell Animal Hospital
2405 Sportsman Drive
Phenix City, Alabama 36867
Dear Dr. Caldwell:
On August 12-14, 2013, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. Our investigation revealed your practice caused the human drug, Gentak (gentamicin sulfate) Ophthalmic Ointment USP, 0.3%, (b)(4), to be unsafe under Section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 USC 360b(a)(1)] and adulterated within the meaning of Section 501(a)(5) of the Act [21 USC 351(a)(5)] because your practice did not comply with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 CFR 530). Your actions resulted in an animal being offered for sale for slaughter as food which was adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act, [21 USC 342(a)(2)(C)(ii)]. You can find the Act and its associated regulations on the Internet through links on FDA’s Internet home page at www.fda.gov.
The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with Sections 512(a)(4) and (5) of the Act, [21 USC 360b(a)(4) and (5)], and 21 CFR 530. Our investigation found you failed to comply with the requirements of 21 CFR 530, in that the human drug, Gentak (gentamicin sulfate) Ophthalmic Ointment USP, 0.3%, (b)(4), which you prescribed and dispensed to your client, (b)(4), (b)(4), was used for an extralabel use in the treatment of an eye infection of his beef cow. Specifically, you prescribed extralabel use of this drug in a food-producing animal and did not meet the requirements of 21 CFR 530.20(a)(2)(ii) and (iv), which require you to:
(ii) Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable; and
(iv) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment.
The above is not intended to be an all-inclusive list of violations. As a licensed veterinarian, you are responsible for complying with the requirements of the Act, including the extralabel use regulations promulgated under the Act. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure these 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 15 working days of receiving this letter. Your response should include each step taken, or will be taken, to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, 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 corrections have been made, which may assist us in evaluating your corrections.
Your written response should be sent to Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Mrs. Dutzek at (615) 366-7826.
Patricia K. Schafer
New Orleans District
Robert E. Pitman, D.V.M., President
Alabama State Board of Veterinary Medical Examiners
8 Commerce Street - Suite 910
Montgomery, Alabama 36130-5330
Scott E. Seebohm, D.V.M., Deputy Director
United States Department of Agriculture Food Safety and Inspection Service
Office of Policy and Program Development
Policy Development Division
1616 Capitol Ave, Suite 260
Omaha, Nebraska 68102