Inspection Record

Smith & Nephew Inc. — Health Canada Inspection Findings

Health CanadaInspected 2022-03-09 3 findingsQuality unit oversightTraining and personnelRegulatory reporting and change control

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

Findings

1Quality unit oversight

The annual product quality review procedure was inadequate.

2Training and personnel

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

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 2022-03-09. 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

Smith & Nephew Inc. company profile — full history Health Canada documents, 2022 Go to Findings search