1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
Serum Institute of India Pvt. Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Aseptic processing and sterility assurance
The company did not verify the sterilization process at scheduled intervals or after significant modifications.
5Aseptic processing and sterility assurance
Evaluation of production processes, equipment, and/or materials was inadequate. The samples taken for sterility testing were not representative of the whole batch.
6Aseptic processing and sterility assurance
The company did not adequately validate radiation sterilization.
7Aseptic processing and sterility assurance
The company's monitoring and documentation of moist heat sterilization cycles was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-11-17. 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.
