1Stability 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 .
Inspection Record
Medisca Pharmaceutique Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.
3Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Other quality system
The assessment to release finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-01-30. 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.
