1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Isologic Innovative Radiopharmaceuticals Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
5Other quality system
The environmental sampling methods were inadequate.
6Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-07-15. 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.
