1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
SGS 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 system for reviewing, revising, and approving standard operating procedures was inadequate.
3Laboratory and QC controls
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products. The design, equipment, and/or maintenance of the testing laboratory was inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-11. 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.
