1Other quality system
The suitability of the culture media was not verified.
Inspection Record
Sylvia Fedoruk Canadian Centre for Nuclear Innovation — 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.
3Equipment and facility
The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
4Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
5Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
6Stability and storage
The temperature and/or humidity control was inadequate.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-08-19. 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.
