1Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
Inspection Record
Novartis Pharmaceuticals Canada Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The assessment to release finished products was inadequate.
3Quality unit oversight
The annual product quality review procedure was inadequate.
4Other quality system
The recorded information or details were inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Other quality system
The implementation of a self-inspection program was inadequate.
8Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-01-14. 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.
