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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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Facet Technologies, LLC - Close Out Letter 10/27/11

  

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

Public Health Service
Food and Drug Administration
 

Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
 

October 27, 2011

VIA UPS

Kevin Seifert, CEO
Facet Technologies, LLC
112 Town Park Drive
Suite 300
Kennesaw, GA 30144

Dear Mr. Seifert:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter# 11-ATL-09, dated May 19, 2011. Based on our evaluation, it appears that you have addressed the violations contained in the 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/

Lakisha N. Morton
Compliance Officer
Atlanta District
 

 

Cc:
Howard Baker, Vice President of Quality & Regulatory Affairs
Facet Technologies, LLC
112 Town Park Drive
Suite 300
Kennesaw, GA 30144
 

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