FDA 483 - Roche Diagnostics Operations, Inc. - June 27, 2019

This FDA Form 483 was issued to Roche Diagnostics Operations, Inc. in Indianapolis, IN, following an inspection of their role as a sponsor for an investigational study. The inspection revealed that proper monitoring was not ensured, specifically regarding adherence to the Study Monitoring Plan and timely review of data at an investigator site. This resulted in several instances where data monitoring was significantly overdue.