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ORA Inspectional References
Guide to Inspections of Quality Systems

For more information about this program and the publication please refer to the following Link to the CDRH QSIT Page. Please refer to this link for Workshop information. The publication is available on the Web in two formats:

QSIT Guide (Web Browser version)

PDF Information: QSIT Guide (Adobe PDF version for printing, 952KB) 

"Acrobat Reader" is required to view the PDF version.  If you do not have it installed on your computer, select the following link to download a free copy.

 Link for Acrobat Reader  


This document was developed by the Quality System Inspections Reengineering Team Members

Office of Regulatory Affairs

Rob Ruff
Georgia Layloff
Denise Dion
Norm Wong

Center for Devices and Radiological Health

Tim Wells - Team Leader
Chris Nelson
Cory Tylka


Chet Reynolds
Kim Trautman
Allen Wynn

Designed and Produced by Malaka C. Desroches

Link to QSIT Guide (Web browsing)