1Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
Inspection Record
Isologic Innovative Radiopharmaceuticals of Ontario Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
3Validation and qualification
The number of personnel with the necessary qualifications and/or on-site experience was inadequate.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-06-11. 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.
