Inspection Record

Sumitomo Pharma Canada, Inc. — Health Canada Inspection Findings

Health CanadaInspected 2023-10-23 3 findingsDeviation, CAPA, and investigationRegulatory reporting and change controlOther quality system

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.

3Other quality system

The importer and/or the distributor's compliance with the current master production documents and/or the marketing authorization was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2023-10-23. 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.

Sumitomo Pharma Canada, Inc. company profile — full history Health Canada documents, 2023 Go to Findings search