1Equipment and facility
Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified. The procedures to identify the contents of each container were inadequate.
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
2Other quality system
The implementation of a self-inspection program was inadequate.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Equipment and facility
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-12-02. 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.
