1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
CDMV Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The quality control department did not undertake all of the required activities. Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
3Stability and storage
The temperature and/or humidity control was inadequate. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
4Other quality system
The electronic system was not validated for its intended use. The controls put in place for electronic signatures were inadequate.
5Equipment 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-19. 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.
