1Other quality system
The recorded information or details were 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
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Material and supplier control
Testing was not performed after raw materials were received on the premises of the drug fabricator.
4Laboratory and QC controls
The specifications approved by the quality control department were not available for all raw materials used to produce drugs.
5Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
8Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-02-08. 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.
