Glossary
Root Cause Analysis (RCA)
Analysis that finds the underlying cause and contributing factors of a problem so that corrective and preventive action can be matched to the cause.
Source · WHO Quality Assurance of Medicines Terminology Database; ICH Q10 §3.2.2 CAPA System
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You did not provide a response regarding your investigations failing to include root cause analysis and extension to other lots that may have been associated.
FDA · FDA Warning Letter · 2024-10-22 -
In response to Observation 6, you stated that CAPA #001, “Quality Program Continuous Improvement and Enforcement” was initiated that includes drafting a new SOP on how to perform investigations detailing root cause analysis to be completed by April 2022.
FDA · FDA Warning Letter · 2022-05-31 -
Your response lacks a retrospective review plan for released batches (b)(4) , (b)(4) and fails to include a root cause analysis for why incomplete…
FDA · FDA Warning Letter · 2026-03-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database; ICH Q10 §3.2.2 CAPA SystemGRM Regulatory Glossary
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