FDA warning letters provide insight into the most common inspection findings so clinical investigators can prevent them.
Each year, IMARC reviews these findings of the previous year's FDA inspections to understand the issues and how we can help teams better prepare to pass with planning, monitoring, auditing and training.
FDA warning letters for 2019 revealed deficiencies ranging from protocol deviations to inadequate records, reporting failures and more.
In 2019, there were 779 BIMO inspections of clinical investigators and 13 inspections of sponsor-investigators. Of those, three resulted in official regulatory action.
Our latest whitepaper summarizes the top FDA inspection findings.
Download it now to discover what they are and how to prevent them.