1Equipment 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.
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
2Stability and storage
The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
3Other quality system
The implementation of a self-inspection program was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Other 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 2023-06-20. 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.
