1Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas 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
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Other quality system
The controls put in place for electronic signatures were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-08-21. 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.
