Inspection Record

AstraZeneca Pharmaceuticals LP — Health Canada Inspection Findings

Health CanadaInspected 2026-04-27 6 findingsOther quality systemQuality unit oversightLaboratory and QC controlsDeviation, CAPA, and investigationComputer system validationRegulatory reporting and change control

View the regulator's official source The source document is always the basis for judgement.

Findings

1Other quality system

The retention time for records was inadequate.

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.

AstraZeneca Pharmaceuticals LP company profile — full history Health Canada documents, 2026 Go to Findings search