Inspection Record

Canadian Molecular Imaging Probe Consortium (CanProbe) — Health Canada Inspection Findings

Health CanadaInspected 2021-05-31 4 findingsComputer system validationAseptic processing and sterility assuranceOther quality system

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

Findings

1Computer system validation

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

2Aseptic processing and sterility assurance

The process was inadequate for the environmental classification of aseptic or clean areas.

3Other quality system

The handling of standard operating procedures for good manufacturing practices was inadequate.

4Computer 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 2021-05-31. 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.

Canadian Molecular Imaging Probe Consortium (CanProbe) company profile — full history Health Canada documents, 2021 Go to Findings search