1Other quality system
The recorded information or details were inadequate.
Inspection Record
Sivem Pharmaceuticals ULC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
3Other quality system
The electronic system was not validated for its intended use.
4Stability 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.
5Other quality system
The company's oversight of the contracted party was inadequate. Complete testing was not performed according to the requirements.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-21. 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.
