1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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
2Equipment 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.
3Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
4Aseptic processing and sterility assurance
The number of samples taken for environmental monitoring was insufficient. The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
5Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
6Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
7Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-05-10. 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.
