FDA medical device investigator provides insights on inspection

— New Q&A Article Released

June 26, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — SALT LAKE CITY, Utah — Many medical device firms receive Form 483 citations from the FDA because of issues related to quality audits, corrective and preventive actions, employee training records, documentation control, etc. Today MasterControl posted an important article on facility inspections from a medical device specialist with the FDA’s Office of Regulatory Affairs.

To download your copy, please click below:


In this Q&A article, MasterControl interviews a medical device specialist with the FDA’s Office of Regulatory Affairs (ORA), who has been inspecting domestic and international medical device companies for the past 12 years. Among other things, the investigator analyzes:

— 12 most common problems of medical device firms pertaining to quality audit.
— Things that FDA investigators look for in terms of CAPA.
— Things that FDA investigators look for in terms of training control.
— How medical device companies can apply “risk-based” approach in quality management.
— What medical device firms should do to prepare for an FDA inspection.


MasterControl Inc. has been at the forefront of providing innovative quality management software solutions since 1993. Over 400 companies worldwide use the MasterControl(TM) solution to consistently meet FDA regulations, ISO standards, and other regulatory requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. For more information or additional white papers, visit:
or call 800-825-9117.


Jason Clegg
MasterControl Inc
6322 S 3000 E Ste 300
Salt Lake City UT USA 84121
800-825-9117 phone
801-942-4000 phone
[email protected]


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