Inspection Record

Sylvia Fedoruk Canadian Centre for Nuclear Innovation — Health Canada Inspection Findings

Health CanadaInspected 2022-09-20 3 findingsEquipment and facilityDeviation, CAPA, and investigationAseptic processing and sterility assurance

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.

2Deviation, CAPA, and investigation

Investigations into deviations, reports, and/or follow-up actions were inadequate.

3Aseptic processing and sterility assurance

The company's cleaning of the premises and the equipment in aseptic areas was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2022-09-20. 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.

Other records for this company

2024-08-19 · Health Canada · 7 findings
Sylvia Fedoruk Canadian Centre for Nuclear Innovation company profile — full history Health Canada documents, 2022 Go to Findings search