1Laboratory and QC controls
The quality control department did not undertake all of the required activities.
Inspection Record
Janssen 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.
3Equipment 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.
4Other quality system
The recorded information or details were inadequate.
5Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-04-27. 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.
