1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Genvion Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
4Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
5Other quality system
Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-05-29. 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.
