1Other quality system
The implementation of a self-inspection program was inadequate.
Inspection Record
Zee Medical Canada — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Other quality system
The electronic system was not validated for its intended use. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records 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.
8Other quality system
The assessment to release finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-17. 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.
