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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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lntersurgical Limited - Close Out Letter 4/27/12


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Si lver Spring, MD 20993-0002

APR 27, 2012

Mr. Roger Le Poidevin
Regulatory Affairs Director
lntersurgical Limited
Crane House
Molly Millars Lane
Berkshire RG41 2RZ
United Kingdom

Dear Mr. Le Poidevin:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS case# 251294, dated December 27, 2011. 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.



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