1Other quality system
The company's monitoring of water testing was inadequate.
Inspection Record
SUN Pharmaceutical Medicare Limited (SPML) — 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 operators'aseptic practices were inadequate to maintain sterility.
3Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
4Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
5Other quality system
The environmental sampling methods were inadequate.
6Other quality system
The company's visual inspection of filled containers was inadequate.
7Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-30. 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.
