1Other quality system
Complete testing was not performed according to the requirements.
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
2Computer system validation
Evaluation of production processes, equipment, and/or materials was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Deviation, CAPA, and investigation
The company's investigations of microbial contamination in critical areas were inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
6Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
7Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
8Aseptic processing and sterility assurance
The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
9Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
10Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
11Complaint and recall handling
The written procedures for recalls were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-01-11. 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.
