1Other quality system
Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative.
Inspection Record
Cliantha Research Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The firm did not maintain all source documentation for bioanalytical studies.
3Other quality system
The firm was unable to account for missing sample volume in samples from studies a.
4Other quality system
The firm reported inaccurate data in the bioanalytical report for study | O@i).
About this record
Extracted automatically from the document US FDA published on 2026-07-13. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
