1Stability and storage
The temperature and/or humidity control was inadequate.
Inspection Record
Sun Pharmaceutical Industries, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Other quality system
The company's visual inspection of filled containers was inadequate.
4Other quality system
The written sanitation program for clean areas was inadequate.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
7Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
8Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
9Other quality system
The recorded information or details were inadequate.
10Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
11Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
12Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
13Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
14Aseptic processing and sterility assurance
The company did not adequately protect sterilized material to prevent re-contamination after sterilization. The operators'aseptic practices were inadequate to maintain sterility.
15Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-05. 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.
