Inspection Record

Ropack Inc. — Health Canada Inspection Findings

Health CanadaInspected 2025-05-06 5 findingsLaboratory and QC controlsRegulatory reporting and change controlOther quality systemComputer system validation

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

Findings

1Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

2Regulatory reporting and change control

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

3Laboratory and QC controls

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

4Other quality system

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

5Computer 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 2025-05-06. 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

Ropack Inc. company profile — full history Health Canada documents, 2025 Go to Findings search