FDA 483 - GE Healthcare Inc. - Life Sciences - March 08, 2024

An FDA inspection of GE Healthcare Inc. - Life Sciences in Marlborough, MA, identified a significant issue related to the conduct of a clinical investigation. The firm failed to ensure that a study was carried out according to its general investigational plan and protocols. Specifically, data from subjects with uninterpretable image quality were improperly included in the Intent to Treat analysis, compromising the study's integrity.