1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Amgen Canada Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
4Laboratory and QC controls
Confirmatory testing was not performed by an alternate laboratory. Periodic confirmatory testing was not conducted.
5Other quality system
The assessment to release finished products was inadequate. The availability or the content of the authentic certificate of analysis was inadequate. The content of the batch certificate was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-01. 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.
