Inspections, Compliance, Enforcement, and Criminal Investigations

Rebecca W. Allen, DVM, PLLC 3/18/15

  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
WARNING LETTER
CMS # 451591
 
VIA UPS Next Day Air
 
March 18, 2015
 
 
Dr. Rebecca W. Allen, Owner
Rebecca W. Allen, DVM, PLLC
2204 Jersey Rd.
Vergennes, Vermont 05491
 
 
Dear Dr. Allen:
 
On November 24, December 3, and December 17, 2014, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. That investigation revealed that you caused animal drugs to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act,  21 U.S.C. § 351(a)(5), because the drugs you prescribed were used in a manner that did not conform with their approved uses or the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (21 C.F.R.), Part 530 (21 C.F.R. Part 530).
 
The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4) and 512(a)(5) of the FD&C Act and 21 C.F.R. Part 530. Our investigation found that you failed to comply with 21 CFR Part 530 in that:
 
1.    You prescribed the human drug Meloxicam Tablets, USP (NDC # (b)(4)) to be administered orally to treat down cows and for supportive treatment therapy related to calf scours and pneumonia at the (b)(4). You also prescribed the new animal drug (b)(4) (Ampicillin, NADA (b)(4)) for the treatment of pneumonia and metritis at the (b)(4). Your prescription for the extralabel use of these drugs did not meet the requirements of 21 C.F.R.  530.20(a)(2)(ii), 530.20(a)(2)(iii), and 530.20(a)(2)(iv), which require that you:
 
(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;
(iii)    Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; 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.
 
2.    Your prescription for the extralabel use of Meloxicam and (b)(4) did not meet the requirements of 21 C.F.R. 530.12(c) and 530.12(e) which require that you  provide labeling information that shall include the following:
(c)    Any directions for use specified by the veterinarian, including the class/species or identification of the animal or herd, flock, pen, lot or other group of animals being treated, in which the drug is intended to be used; the dosage, frequency, and route of administration; and the duration of therapy; and,
(e)    The veterinarian’s specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food which might be derived from the treated animal or animals.
 
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 FD&C Act, including the extralabel use regulations promulgated under the FD&C Act. 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.
 
FDA acknowledges the written response we received following our inspection. A letter dated December 30, 2014 was received addressing the observations made during the inspection conducted on November 24, December 3, and December 17, 2014. Although your letter indicates that you will take steps to address our observations, we find that it is inadequate to specifically address all of the violations noted above and you did not provide specific documentation of your reported corrections. 
 
We have enclosed a copy of 21 C.F.R. Part 530 for your reference. We strongly suggest that you review 21 C.F.R. Part 530 and become familiar with all of its requirements so that you can prevent future violations of the FD&C Act.
 
You should notify this office in writing of the steps you have taken to be in 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 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 that corrections have been made. 
 
Your written response should be sent to the Food and Drug Administration, Attention: Scott M. Loughan, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 x 1109.
 
Sincerely,
/S/ 
Lori Holmquist
Acting District Director
New England District

Page Last Updated: 03/24/2015
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