1Laboratory and QC controls
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The design, equipment, and/or maintenance of the testing laboratory was inadequate.
Inspection Record
Pathogenia Inc. — 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.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Laboratory and QC controls
The validation of test methods was inadequate.
5Equipment and facility
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The maintenance of records was inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-13. 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.
