Atlas · Analytics
FDA inspection statistics and compliance analytics
9dashboards built from Atlas's inspection data: FDA inspections by year and country, the most cited CFR sections and ISO 13485 clauses, complete response letters, and EMA and Health Canada inspections. Each page shows a free window, with the complete data available on request.
US FDA Inspections Analytics
US FDA inspections analytics: inspections by year and country for 2024 to 2026, the most cited CFR sections and keyword trends. 31,317 FDA inspections in 2025.
Open analyticsINDIA - Human Drugs - Trends
FDA inspections of Indian human drug facilities by month for 2026, the Form 483 rate and the most cited 21 CFR 211 sections. 339 inspections in 2025, 61% with a Form 483.
Open analyticsRegion Wise Top Issues
The most cited FDA inspection issues by region for medical devices and human drugs. Procedures and process validation lead device findings in every region Atlas tracks.
Open analyticsMost Prevalent CFRs by GXP and Industry
The most cited 21 CFR sections in FDA inspections by year. 21 CFR 211.22(d) led 2024 with 175 citations, ahead of 211.192 and 211.100(a). Filter by GxP and industry.
Open analyticsEMA Annual Report
EMA Good Clinical Practice inspections in 2023 by region and type of site, from the GCP Inspectors Working Group annual report. 67 inspections, 46 at clinical investigator sites.
Open analyticsHealth Canada Inspections Report
Health Canada GMP and GVP inspection outcomes for 2023 and 2024 and the most cited Food and Drug Regulations sections. 982 inspections in 2024, 2.4% non-compliant.
Open analyticsComplete Response Letter (CRL)
What a complete response letter is and why the FDA issues them, from Atlas's analysis of published CRLs. 65 letters in 2024; 42 of them cited facility inspection problems.
Open analyticsAverage Observations per Inspection
How many observations the FDA writes on a Form 483, by year. 3.20 observations per inspection in 2025 across 5,073 inspections with a Form 483, down from about 4 in the early 2010s.
Open analyticsMost Prevalent ISO Clauses by Industry
Which ISO 13485 clauses the FDA cites most on device Form 483s since the QMSR took effect. 91 of 96 device 483s from May to July 2026 cited ISO 13485; clause 7.1 led at 31%.
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