1Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
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
The company did not adequately protect sterilized material to prevent re-contamination after sterilization.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Computer system validation
The design, construction, and/or location of the equipment did not allow adequate cleaning, sanitizing, and/or inspection of the equipment. The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
7Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
8Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-06-02. 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.
