Inspection Record

Apotex Inc — Health Canada Inspection Findings

Health CanadaInspected 2021-01-11 3 findingsDeviation, CAPA, and investigationRegulatory reporting and change controlLaboratory and QC controls

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

Findings

1Deviation, CAPA, and investigation

Investigations into deviations, reports, and/or follow-up actions were inadequate.

2Regulatory reporting and change control

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

3Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2021-01-11. 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.

Other records for this company

2026-04-13 · Health Canada · 5 findings2025-05-09 · US FDA · 10 findings2025-11-10 · Health Canada · 5 findings2025-11-04 · US FDA · 3 findings2025-04-14 · Health Canada · 12 findings2024-09-09 · Health Canada · 6 findings
Apotex Inc findings history — including this company's other documents Health Canada documents, 2021 Go to Findings search