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FDA Enforcement Themes | AgentQ

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Enforcement Themes

The root-cause themes FDA actually cites: recurring failure patterns that cut across CFR codes. See what firms keep getting written up for, where each theme is heading, and what to do about it.

Distinct Themes1,168

Citations, 2021 to 202610,204

Rising in Top 149

Cooling in Top 145

Net-New Themes8+

The Leading Edge: Net-New Themes

Cited in 2024 to 2026, absent in 2021 to 2023

Field Alert ReportNet-NewPremarket Authorization ComplianceNet-NewSoftware Lifecycle ManagementNet-NewDrug Labeling and AdvertisingNet-NewMedical Device ReportingNet-NewDrug Labeling and MisbrandingNet-New

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Showing 14 of 1,168 ThemesSort By

Themes are extracted from the root-cause analysis of each warning-letter violation and clustered across the full set. Trend compares 2024 to 2026 against 2021 to 2023.