7-Year Review of GCP Inspections Finds Fewer 483s
August 20th, 2025 // 9:38 pm @ jmpickett
An FDA review of 2,386 Good Clinical Practice (GCP) inspections conducted between 2017 and 2023 shows a marked decline in regulatory violations at clinical trial sites. The proportion of inspections resulting in Form 483 observations dropped from 23.5% in 2017 to 10.4% in 2023, with just 0.3% escalating to official action. Most inspections concluded with no action indicated (81.2%), while 18.5% required voluntary corrections and only a fraction required enforcement.
The most frequent deficiencies involved protocol compliance and record-keeping. Contract research organizations (CROs) fared particularly well, with over 90% of inspections requiring no FDA follow-up. The pandemic temporarily reduced inspection volume in 2020 and led to more findings being downgraded from voluntary to no action.
Authors attribute the overall decline in violations to advances such as electronic systems, remote monitoring, updated GCP guidelines (2018), and stronger training and oversight by sponsors. However, some experts caution that the trend could also reflect fewer inspections, less experienced investigators, or reduced scrutiny rather than true improvements in compliance.
In sum: While nearly all inspections (99.7%) required no official action, the data leave open questions about inspection rigor and whether the decline truly signals stronger adherence to GCP standards.
