1Equipment and facility
Evaluation of production processes, equipment, and/or materials 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
2Laboratory and QC controls
The specifications approved by the quality control department were not available for all raw materials used to produce drugs.
3Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate. The company's oversight of the contracted party was inadequate.
4Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate. The evidence required to demonstrate compliance with finished product specifications was inadequate.
5Laboratory and QC controls
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The design, equipment, and/or maintenance of the testing laboratory was inadequate.
6Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification.
7Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate. The quality control department did not undertake all of the required activities.
9Contamination 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 2025-09-22. 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.
