1Other quality system
The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
Inspection Record
Lupin Pharma Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. The quality control department's handling of complaints and/or information received about drug quality was inadequate.
3Equipment and facility
Documents were not available on the premises. The maintenance of records was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate.
5Other quality system
The written self-inspection procedure was inadequate.
6Complaint and recall handling
The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-07-22. 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.
