1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Merz Pharma Canada Ltd — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
3Other quality system
The controls put in place for electronic signatures were inadequate.
4Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
5Other quality system
The master production documents were inadequate. Documents were not available in one of the official languages.
6Stability and storage
For imported products, the stability studies from foreign sites were not compliant with Canadian good manufacturing practices and/or Canadian marketing authorization.
7Complaint and recall handling
The written procedures for recalls were inadequate.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-10. 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.
