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  5. Smith & Nephew, Inc. - 12/14/2016
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Smith & Nephew, Inc.

Smith & Nephew, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



New England District Office (NWE-DO)
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500 

December 14, 2016

Michael G. Frazette. President
Advanced Surgical Devices
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810

Dear Mr. Frazette:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated April 30, 2015, CMS # 457814. Based on our evaluation, it appears that you have addressed the violations 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.

If you have questions regarding any issues in this letter, please contact me at 781-587-7491 or at karen.archdeacon@fda.hhs.gov.


Karen Archdeacon
Compliance Officer
New England District

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