FDA 483 - Bluewater Diagnostic Laboratory - October 13, 2022

Bluewater Diagnostic Laboratory, a clinical investigator in Mount Washington, KY, received a Form 483 with five observations following an FDA inspection. The findings indicate significant issues with the conduct of a clinical study, including failures in adhering to investigational plans, obtaining proper informed consent, maintaining complete and accurate subject records, and ensuring IRB approval for study amendments. These deficiencies highlight a lack of control over critical aspects of human subject protection and data integrity in clinical research.