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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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LCA Vision Inc/Lasik Plus Vision Center - Close Out Letter 8/16/11

  

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

 

AUG 16 2011


Ms. Nancy L. Rust
Patient Care Manager
LCA Vision, Inc.
Corporate Headquarters
7840 Montgomery Road
Cincinnati, Ohio 45236

Dear Ms. Rust:

The Food an,d Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to Warning Letters issued to LCA Vision, Inc., user facilities from October, 2009, through April, 2010. Based on our evaluation, it appears that you have addressed the violations contained in these Warning Letters. 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