1Laboratory and QC controls
Written procedures are not established for critical laboratory tasks.
Inspection Record
Clongen Laboratories, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Quality oversight is inadequate.
3Equipment and facility
Equipment is not qualified or monitored for its intended use.
4Laboratory and QC controls
Quality control documentation and practices are inadequate.
5Other quality system
A quality agreement defining the roles and responsibilities of each involved party is not established.
6Validation and qualification
Employee training and qualification is inadequate.
About this record
Extracted automatically from the document US FDA published on 2026-07-24. 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.
