1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
MSS Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
The ongoing training of personnel was inadequate.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Equipment 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.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Stability 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.
8Other quality system
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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-10. 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.
