The Persistence of Predictable Inspection Findings
Health authority inspection findings in the pharmaceutical and medical device sector are not unpredictable. The same categories appear in FDA Form 483 observations, EMA GMP non-compliance reports, and MHRA GxP inspection findings year after year. In 2024 and 2025, three categories — data integrity, CAPA effectiveness, and computerised system controls — appeared in over 70% of inspections with significant findings across all three jurisdictions.
This whitepaper analyses 2024–2025 inspection data across all three major health authorities and provides the site-level remediation framework for each finding category.
Top 3Data integrity, CAPA effectiveness and computerised system controls in top three finding categories across FDA, EMA and MHRA in 2024–2025
68%of inspections with major or critical findings include at least one data integrity observation
22FDA Warning Letters related to data integrity or CAPA failures in pharmaceutical manufacturing in 2024
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About AjaCertX
AjaCertX is a specialist compliance, certification and assurance partner serving life science organisations. Our GxP practice delivers inspection readiness programmes, mock inspections and CAPA remediation.