1Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
Inspection Record
Lupin Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
3Equipment and facility
The maintenance and/or monitoring of the ventilation system's air quality was inadequate.
4Equipment and facility
The maintenance of records was inadequate.
5Quality unit oversight
The annual product quality review procedure was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Equipment 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.
8Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-13. 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.
