FDA 483 - GE Healthcare - Repair Operations Center - July 18, 2023

An FDA inspection of GE Healthcare - Repair Operations Center in Oak Creek, WI, a medical device remanufacturer, identified one observation. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established, specifically regarding the documentation of nonconformances and CAPAs using an unreferenced electronic software system. This indicates a moderate severity issue related to quality system documentation and control.