1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
Hoffmann-La Roche Limited — 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.
3Laboratory and QC controls
Periodic confirmatory testing was not conducted. Confirmatory testing was not performed by an alternate laboratory.
4Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Equipment 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.
6Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
7Other quality system
The assessment to release finished products was inadequate.
8Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-25. 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.
