1Other quality system
The retention time for records was inadequate.
Inspection Record
AstraZeneca Pharmaceuticals LP — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-04-27. 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.
