483
Alcon Research, LTD.Alcon Research, LTD. – FDA 483, Feb 23, 2018
Record Details
Alcon Research, LTD. in Sinking Spring, PA, a device manufacturer, was cited for inadequate procedures for receiving, reviewing, and evaluating complaints. The inspection revealed issues with missing lot code information, inconsistent application of 'As Reported Terms' and 'Event Codes', and non-uniform utilization of fields for complaint data analysis, particularly concerning the CyPass 241 device. These deficiencies indicate significant problems in their complaint handling system.
View Company Profile
ID · 20f93b74-ac1e-45ea-8643-4e6bcd161853
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.