1Equipment and facility
The maintenance of the premises was inadequate.
Inspection Record
Solex Pharma Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The temperature and/or humidity control was inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Laboratory and QC controls
The quality control department did not undertake all of the required activities.
6Equipment and facility
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-11. 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.
