1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
Dentsply Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
3Equipment 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.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Stability and storage
The temperature and/or humidity control was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
8Stability and storage
The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-25. 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.
