1Laboratory and QC controls
The evidence required to demonstrate compliance with finished product specifications was inadequate. Confirmatory testing was not performed by an alternate laboratory.
Inspection Record
Alexion Pharma Canada Corp — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
3Equipment and facility
The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-17. 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.
