1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Jubilant Hollisterstier General Partnership — 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 maintenance of records was inadequate.
4Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
5Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-12. 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.
