1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
Dormer Laboratories Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Other quality system
The written specifications were inadequate.
6Other quality system
The assessment to release finished products was inadequate.
7Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Equipment 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.
10Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
11Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-11. 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.
