1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Knight Therapeutics Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate.
3Complaint and recall handling
The written procedures for recalls were inadequate.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Equipment and facility
The maintenance of records was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-08. 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.
