1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products 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
2Stability and storage
The temperature and/or humidity control was inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
6Equipment and facility
The maintenance of records was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
9Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-20. 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.
