1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Nora Pharma Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
3Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use. The controls put in place for electronic signatures were inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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. The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
6Stability 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 2022-03-23. 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.
