1Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
Inspection Record
Sanofi Vaccines Canada Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Evaluation of production processes, equipment, and/or materials was inadequate. The operators'aseptic practices were inadequate to maintain sterility.
3Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
4Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-06-11. 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.
