1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
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
2Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
3Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
4Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions. The protection of products and/or materials from contamination was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
6Deviation, CAPA, and investigation
The assessment to release finished products was inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The analysis of trends for batches of drugs that differed from the norm was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Training and personnel
The ongoing training of personnel was inadequate.
9Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-13. 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.
