1Material and supplier control
The drug fabricator's specifications for raw materials were 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
2Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
3Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
4Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
5Laboratory and QC controls
Precautions were not taken to ensure that containers were free from contamination by foreign material. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.
6Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Aseptic processing and sterility assurance
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend. For sterile drugs, the stability program did not include a confirmation of sterility at the initial testing and at the end of the drug's shelf life.
8Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
9Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
10Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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.
