1Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
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
2Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
3Training and personnel
The ongoing training of personnel was inadequate.
4Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
5Aseptic processing and sterility assurance
The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
6Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
8Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
9Aseptic processing and sterility assurance
The company did not validate the sterility test of the finished product.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-03-08. 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.
