Recipient: General Electric Inc.
Product: X-ray and fluoroscopic systems
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