1Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
Inspection Record
Edmonton Radiopharmaceutical Centre (Alberta Health Services) — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
3Equipment and facility
The maintenance of records was inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-05-15. 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.
