1Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
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
2Other quality system
The written clothing standards for each environmental grade were inadequate.
3Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate. The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
4Stability and storage
The temperature and/or humidity control was inadequate.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
7Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. Warning systems did not alert personnel when air pressure fell below established limits.
9Other quality system
The company's visual inspection of filled containers was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-04. 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.
