1Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
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
2Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
5Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
6Other quality system
Critical production processes were not validated.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-19. 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.
