1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Takeda Pharmaceutical Company Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
3Other quality system
The written sanitation program for clean areas was inadequate.
4Other quality system
The airborne particle monitoring system was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-11. 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.
