2023 Clinical 483 Inspection Observations Trends

Apr 8, 2024 | White Paper |

CLI-2402 Teaser Pic

First Quarter 2024 Clinical 483 Inspection Observations are Tracking to 2023 Trends. How to Stay Ahead with a Winning Strategy!

Are you curious about different ways to avoid a 483 violation? Then this MEDIcept White Paper is for you! 

Each year, FDA compiles a list of 483 inspection observations into a dataset, summarizing ways companies have violated FDA regulations throughout that fiscal year (FY). In fiscal year 2023, there were 720 observations issued for medical devices, 45 for biologics, 96 for human tissue for transplantation, and 158 for bioresearch monitoring included in the dataset.  

In this paper we present the top 6 clinical inspection observation trends identified in FY 2023; which section of the federal regulations were violated; and how sites, sponsors, and/or contract research organizations (CROs) can implement strategies to minimize the possibility of receiving a 483 violation when an FDA inspector knocks on their door.  

Click now to read the latest MEDIcept White Paper!