1Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
Inspection Record
Sylvia Fedoruk Canadian Centre for Nuclear Innovation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
The ongoing training of personnel was inadequate.
3Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Equipment and facility
The maintenance of records was inadequate. The electronic system was not validated for its intended use.
6Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas. 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 2026-08-24. 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.
