1Stability and storage
The ongoing stability program for a drug was inadequate.
Inspection Record
Thunder Bay Regional Health Sciences Centre — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
5Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-15. 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.
