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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Vascular Group PLLC - Close Out Letter 8/3/12

  

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

 

AUG 3, 2012

Manish Mehta, MD, MPH
The Vascular Group PLLC
The Vascular Health Pavilion
5 West Plaza #501
Albany, NY 12205

Dear Dr. Mehta:

The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter, dated February 21 , 2012. Based on our evaluation, it appears that you have has addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will assess the adequacy and maintenance of these corrections.

This letter does not relieve you of your responsibility to take all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations, as well as other relevant legal authority. The FDA will continue to monitor your state of compliance and this letter will not preclude future regulatory action should violations be observed through inspection or other means.

Sincerely yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health Chief
 

 

cc:

     Western Institutional Review Board, Inc.
     3535 7th Avenue SW
     Olympia, WA 98502-5010