1Other quality system
Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water.
Inspection Record
Novocol Pharmaceutical of Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
5Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
6Other quality system
The recorded information or details were inadequate.
7Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas.
8Other quality system
The company's visual inspection of filled containers was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-12-02. 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.
