1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Pierre Fabre Dermo-Cosmétique Canada 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
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
4Equipment and facility
The ongoing training of personnel was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
6Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
7Equipment 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.
8Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-30. 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.
