Eminent Spine Shares FDA Audit Results
Eminent Spine is pleased to release the results of an unscheduled FDA audit performed between February 28-March 4, 2011.
Georgetown, TX, September 23, 2011 --(PR.com)-- The FDA inspection included the following areas:
-a review of training program(s)
-manufacturing and design operations
-manufacturing and design controls
-corrective and preventive actions
-production and process controls
-process validation
-purchasing controls
-device master records
-complaints and recall procedures
The FDA audit concluded there were no deficiencies noted. Eminent Spine currently has nine spine systems approved by the FDA and is expected to release two new spine implants during the fourth quarter of 2011.
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-a review of training program(s)
-manufacturing and design operations
-manufacturing and design controls
-corrective and preventive actions
-production and process controls
-process validation
-purchasing controls
-device master records
-complaints and recall procedures
The FDA audit concluded there were no deficiencies noted. Eminent Spine currently has nine spine systems approved by the FDA and is expected to release two new spine implants during the fourth quarter of 2011.
###
Contact
Eminent Spine, LLC
Steve Courtney
972.499.3593
www.eminentspine.com
Contact
Steve Courtney
972.499.3593
www.eminentspine.com
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