1Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
Inspection Record
Natco Pharma 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 environmental sampling methods were inadequate. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. The operators'aseptic practices were inadequate to maintain sterility.
5Aseptic processing and sterility assurance
The company did not adequately validate how the sterilizer was loaded. The company's validation of moist heat sterilization was inadequate.
6Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
7Other quality system
The written sanitation program for clean areas was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Aseptic processing and sterility assurance
The samples taken for sterility testing were not representative of the whole batch.
10Other quality system
The company's visual inspection of filled containers was inadequate.
11Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-01-15. 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.
