1Equipment 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.
Inspection Record
Shoppers Drug Mart Specialty Health Network Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Other quality system
The recorded information or details were inadequate.
4Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Other quality system
The implementation of a self-inspection program was inadequate. The written self-inspection procedure was inadequate.
6Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
7Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-03. 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.
