1Other quality system
The airborne particle monitoring system 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
2Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
3Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
5Other quality system
The written clothing standards for each environmental grade were inadequate.
6Other quality system
Tests were not performed according to approved specifications.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-05-27. 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.
