The controls put in place for electronic signatures were inadequate.
Inspection Record
Merle Norman Cosmetics Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The master production documents were inadequate.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
The written procedures for recalls were inadequate.
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
The annual product quality review procedure was inadequate.
The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-04-05. 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.
