1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate.
Inspection Record
Diagnostic Imaging, Nova Scotia Health Authority — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
3Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
4Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
6Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
7Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-07-12. 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.
