Inspection Record

Dentec Safety Specialists Inc. — Health Canada Inspection Findings

Health CanadaInspected 2022-09-13 4 findingsLaboratory and QC controlsOther quality systemRegulatory reporting and change control

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

Findings

1Laboratory and QC controls

The quality control department did not undertake all of the required activities. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

2Other quality system

The implementation of a self-inspection program was inadequate.

3Other quality system

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

4Regulatory 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 2022-09-13. 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.

Dentec Safety Specialists Inc. company profile — full history Health Canada documents, 2022 Go to Findings search