Inspection Record

Moderna Biopharma Canada Corporation — Health Canada Inspection Findings

Health CanadaInspected 2024-06-10 5 findingsLaboratory 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

1Laboratory and QC controls

The procedure was inadequate for documenting quality control decisions by the person in charge of the quality control department. The quality control department was not involved in all decisions for the quality of the product.

2Other quality system

The assessment to release finished products was inadequate.

3Other quality system

The implementation of a self-inspection program was inadequate.

4Deviation, CAPA, and investigation

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

5Equipment and facility

The maintenance of records was inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2024-06-10. 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

Moderna Biopharma Canada Corporation company profile — full history Health Canada documents, 2024 Go to Findings search