1Stability and storage
The ongoing stability program for a drug was 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
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Material and supplier control
The protection of products and/or materials from contamination was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
6Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
7Other quality system
The recorded information or details were inadequate.
8Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
9Equipment and facility
The maintenance of the premises was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-08. 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.
