1Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
Inspection Record
Catalent Ontario Limited — 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. The operation of the water purification equipment was inadequate for ensuring a reliable source of water.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-08-18. 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.
