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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Southern Implants (Pty.) Ltd. Close out Letter 10/9/12

  

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 

OCT 09 2012


Mr. Graham Blackbeard
Management Director
Southern Implants (Pty.) Ltd.
One Albert Road
Irene, Gauteng
South Africa


Dear Mr. Blackbeard:
 


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated February 7, 2011. Based on our evaluation, it appears that your firm has 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, as well as other relevant legal authority. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely yours,
/S/
Director
Office of Compliance
Center for Devices and
Radiological Health