7-Year FDA Inspection Review Finds Better GCP Compliance
August 20th, 2025 // 9:36 pm @ jmpickett
A retrospective FDA study of 2,386 Good Clinical Practice (GCP) inspections (2017–2023) found a sharp decline in regulatory violations at clinical trial sites.
- Form 483s (violations) decreased from 23.5% in 2017 to 10.4% in 2023, with only 0.3% requiring official action.
- Final outcomes: 81.2% no action indicated (NAI), 18.5% voluntary action indicated (VAI), 0.3% official action indicated (OAI).
- Common deficiencies: protocol adherence and record-keeping.
- CROs performed best, with >90% inspections needing no FDA action.
- Pandemic effects: inspection numbers dropped in 2020; more cases were downgraded from VAI to NAI.
Possible drivers of improvement include:
- Wider use of electronic systems and remote monitoring.
- 2018 harmonized GCP guidelines and training programs.
- Better sponsor vetting of sites after fraud cases.
Uncertainties remain:
- Lower violation rates may also reflect fewer inspections, less experienced FDA inspectors, or shifting scrutiny.
- Experts caution against assuming improved compliance without longer-term data.
Bottom line: Nearly all inspections (99.7%) required no official action, suggesting improved GCP practices, though questions remain about inspection intensity and workforce changes.
