1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Shilpa Medicare 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 validation of aseptic processing was inadequate.
3Other quality system
The company's visual inspection of filled containers was inadequate.
4Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
5Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
6Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
7Other quality system
The master formulas to control the manufacturing process were inadequate.
8Other quality system
The written sanitation program for clean areas was inadequate.
9Material and supplier control
The testing or examination of packaging materials was inadequate on a sample received on the premises by a person that packages the drugs.
10Equipment 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 2022-09-12. 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.
