Inspection Record

Tanvex BioPharma Canada, Inc. — Health Canada Inspection Findings

Health CanadaInspected 2024-11-12 4 findingsDeviation, CAPA, and investigationEquipment and facilityRegulatory reporting and change controlQuality unit oversight

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.

2Equipment and facility

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

3Regulatory reporting and change control

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

4Quality unit oversight

The annual product quality review procedure was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-11-12. 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.

Tanvex BioPharma Canada, Inc. company profile — full history Health Canada documents, 2024 Go to Findings search