Glossary
Validation Report
A document comparing validation results against the acceptance criteria and recording deviations, conclusions, and any recommendations.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Furthermore, you did not provide a sterility validation report from (b)(4) for the specific lot number of (b)(4) in question.
FDA · FDA Warning Letter · 2023-08-08 -
The process validation report, GS-2023-025 (dated 07/03/2023) cited multiple samples failing a (b)(4) in endotoxins.
FDA · FDA Warning Letter · 2025-03-11 -
In your response regarding unknown peaks for the UPLC amino acid analysis, in part you state that you have revised your cleaning procedures for laboratory glassware, however, you did not provide a cleaning validation report demonstrating the effectiveness of the new cleaning procedure.
FDA · FDA Warning Letter · 2024-05-21
