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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Wu, Helen K. - Close Out Letter 7/29/11

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

JUL 29 2011


Helen K. Wu, M.D.
Medical Director, Refractive Surgery
New England Eye Center at Tufts Medical Center
800 Washington Street, #450
Boston, Massachusetts 02111

Dear Dr. Wu:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated February 12, 2010. Based on our evaluation, it appears that you have addressed the violation contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,

/s/

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