Inspection Record

Winnipeg Regional Health Authority — Health Canada Inspection Findings

Health CanadaInspected 2024-11-25 5 findingsComputer system validationLaboratory and QC controlsOther quality systemDeviation, CAPA, and investigationEquipment and facility

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

Findings

1Computer system validation

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

2Laboratory and QC controls

The quality control department did not undertake all of the required activities.

3Other quality system

Complete testing was not performed according to the requirements.

4Deviation, CAPA, and investigation

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

5Equipment and facility

Evaluation of production processes, equipment, and/or materials was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-11-25. 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

Winnipeg Regional Health Authority company profile — full history Health Canada documents, 2024 Go to Findings search