1Equipment and facility
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The establishment and/or the maintenance of a data governance plan was inadequate.
Inspection Record
Centre Hospitalier Universitaire de Sherbrooke — 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.
3Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
4Complaint and recall handling
Health Canada was not notified of a recall.
5Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate. The ongoing training of personnel was inadequate.
6Environmental monitoring
The number of samples taken for environmental monitoring was insufficient. The environmental sampling methods were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-05. 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.
