1Stability and storage
The temperature and/or humidity control was inadequate.
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
2Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification 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.
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.
6Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
7Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
10Aseptic processing and sterility assurance
The company did not validate the sterility test of the finished product.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-15. 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.
