1Other quality system
The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
Inspection Record
Pathogenia Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.
6Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Stability and storage
The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-26. 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.
