1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Vivier Canada Incorporated — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability 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. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
3Complaint and recall handling
The written procedures for recalls were inadequate.
4Other quality system
The implementation of a self-inspection program was inadequate.
5Training and personnel
The ongoing training of personnel was inadequate.
6Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
7Equipment and facility
The company's oversight of the contracted party was inadequate. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-30. 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.
