1Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
Inspection Record
Glenmark Pharmaceuticals Canada 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.
3Laboratory and QC controls
The maintenance of records was inadequate. The validation of test methods was inadequate. The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-05-14. 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.
