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U.S. Department of Health and Human Services

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Enforcement Actions

Smith & Nephew Orthopaedics Gmbh - Close Out Letter 6/20/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

 

JUN 20, 2013

 

Oliver Bohuon
CEO
Smith & Nephew PLC
15 Adam Street
London, WC2N 6LA United Kingdom


Dear Mr. Bohuon:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #147052 dated December 21, 2010. 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.

 

Sincerely,

/S/

William C. MacFarland
Director
Division of Enforcement B
Office of Compliance
Center for Devices and Radiological Health