1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification 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 procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
3Stability and storage
The stability studies did not test all drug specifications that are susceptible to change during storage.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
7Laboratory and QC controls
The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-05-25. 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.
