1Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization. The number of samples taken for environmental monitoring was insufficient.
Inspection Record
Sun Pharmaceutical Industries Limited — 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 company's cleaning of the premises and the equipment in aseptic areas was inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Material and supplier control
The specifications for raw materials used to produce drugs did not meet pharmacopoeial standards.
5Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
6Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
9Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. Evaluation of production processes, equipment, and/or materials was inadequate.
10Aseptic processing and sterility assurance
The company's corrective action after a media fill failure or a sterility test failure was inadequate. The company's investigations of microbial contamination in critical areas were inadequate.
11Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
12Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-11-18. 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.
