1Laboratory and QC controls
The validation and/or the documentation of test methods 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
2Equipment and facility
The maintenance of records was inadequate. The electronic system was not validated for its intended use.
3Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
4Laboratory and QC controls
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The quality control department did not undertake all of the required activities.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-08-03. 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.
