1Stability and storage
The frequency of stability testing of a drug did not comply with the marketing authorization.
Inspection Record
Solventum Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Other quality system
The written specifications were inadequate.
4Equipment 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.
5Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
6Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-10. 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.
