Inspection Record

Galenova Inc. — Health Canada Inspection Findings

Health CanadaInspected 2022-12-12 3 findingsOther quality systemEquipment and facilityComputer system validation

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

Findings

1Other quality system

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.

2Equipment and facility

The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.

3Computer 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 2022-12-12. 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.

Other records for this company

Galenova Inc. findings history — including this company's other documents Health Canada documents, 2022 Go to Findings search