1Other quality system
The "Water for Injection" was not produced, stored or distributed to prevent microbial growth.
Inspection Record
Moderna Manufacturing Canada Corp. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Complete confirmatory testing was not conducted on raw materials from each vendor.
3Training and personnel
The health examinations of personnel (pre-employment and/or ongoing) were inadequate.
4Computer 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 2024-08-05. 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.
