Inspection Record

Octapharma Canada Inc — Health Canada Inspection Findings

Health CanadaInspected 2025-08-07 3 findingsDeviation, CAPA, and investigationLaboratory and QC controlsRegulatory reporting and change control

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.

2Laboratory and QC controls

The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department.

3Regulatory 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 2025-08-07. 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.

Octapharma Canada Inc company profile — full history Health Canada documents, 2025 Go to Findings search