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.
Inspection Record
Moderna Biopharma Canada Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The assessment to release finished products was inadequate.
The implementation of a self-inspection program was inadequate.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
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.
