1Other quality system
The evidence required to demonstrate compliance with finished product specifications was 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
2Equipment and facility
The maintenance of records was inadequate.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Other quality system
The control of quarantine areas was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-08-03. 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.
