The root-cause themes FDA actually cites, the recurring failure patterns that cut across CFR codes. This is the layer above the provision ranking: what firms keep getting written up for, where each theme is heading, and the real causes behind it.
1168 distinct themes across 10,204 citations, 2021-2026
The leading edge, themes accelerating fastest
Field Alert Reportnet-newPremarket Authorization Compliancenet-newSoftware Lifecycle Managementnet-newDrug Labeling and Advertisingnet-newMedical Device Reportingnet-newDrug Labeling and Misbrandingnet-new
Themes are extracted from the root-cause analysis on each warning-letter violation and clustered across the corpus. Trend compares the last three years against the prior three.
