Inspection Record

Delpharm Montréal Inc. — Health Canada Inspection Findings

Health CanadaInspected 2024-04-22 5 findingsEquipment and facilityComputer system validationDeviation, CAPA, and investigationOther quality systemContamination control

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

Findings

1Equipment and facility

The maintenance of records was inadequate.

2Computer system validation

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

3Deviation, CAPA, and investigation

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

4Other quality system

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

5Contamination control

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-04-22. 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

Delpharm Montréal Inc. company profile — full history Health Canada documents, 2024 Go to Findings search