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CLOSEOUT LETTER

Valley Health/Winchester Medical Center IRB


Recipient:
Valley Health/Winchester Medical Center IRB

United States

Issuing Office:

United States


  

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

Public Health Service
 Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

July 24, 2015

Jennifer Stanford
Director of Clinical Research
Valley Health/Winchester Medical Center IRB
1840 Amherst Street
Winchester, VA 22601

Dear Ms. Stanford:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective and preventive actions in response to our Warning Letter (WL) dated May 9, 2013. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL.

This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely yours,

/S/

James Saviola, OD, CAPT USPHS
Director, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
    Radiological Health

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