1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
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
2Other quality system
The company's monitoring of water testing was inadequate.
3Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
4Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Training and personnel
The health examinations of personnel (pre-employment and/or ongoing) were inadequate.
7Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
8Aseptic processing and sterility assurance
The documentation for the integrity testing of sterilizing filters was inadequate.
9Equipment and facility
Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
10Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test. Complete confirmatory testing was not conducted on raw materials from each vendor.
11Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
12Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
13Laboratory and QC controls
The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-24. 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.
