1Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
Inspection Record
Merz Aesthetics 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 written specifications were inadequate.
3Complaint and recall handling
The handling of standard operating procedures for good manufacturing practices was inadequate. Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. The quality control department's handling of complaints and/or information received about drug quality was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-13. 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.
