The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Takeda Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
The availability or the content of the authentic certificate of analysis was inadequate.
Periodic confirmatory testing was not conducted.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-02-24. 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.
