1Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
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
2Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
3Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
4Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
6Other quality system
The recorded information or details were inadequate.
7Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-10-23. 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.
