1Other quality system
The system for reviewing, revising, and approving standard operating procedures was inadequate.
Inspection Record
Montreal Neurological Institute — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
4Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate. The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
5Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
6Environmental monitoring
The number of samples taken for environmental monitoring was insufficient.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-05-20. 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.
