1Other quality system
The recorded information or details were inadequate.
Inspection Record
ModernaTX, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
3Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Stability 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.
6Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Laboratory and QC controls
The establishment of specifications was inadequate for packaging materials approved by the quality control department.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
10Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
11Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-01-25. 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.
