General Electric Inc.

Recipient: General Electric Inc.
Product: X-ray and fluoroscopic systems
Date: 3/31/05

For example, your firm uses electronic database systems to document, track, and control corrective and preventive actions. The Correct Action/Preventive Action System procedure, _____, does not reference the use of these database systems, nor does it describe the steps necessary to close corrective and preventive actions. Also, our inspection found that additions and changes had been made to CAPAs after they had been verified or closed. There are no provisions for this in your procedure.

FDA District: Denver District Office

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.