1Aseptic processing and sterility assurance
The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
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
2Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
4Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-30. 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.
