1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Celltrion Healthcare Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The written self-inspection procedure was inadequate.
3Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The controls put in place for electronic signatures were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-12. 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.
