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Data Integrity : Key Lessons from the 2025 FDA Warning Letters Data Integrity Is a Leadership Problem, Not a Regional One: Lessons from 2025 FDA Warning Letters Executive Summary This report provides an evaluation of US FDA Warning Letters issued in calendar year 2025 that cite 21 CFR 211.68(b), focusing on automated and computerized systems used to generate, process, store, and report CGMP data

Li BU, Misiewicz L