1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Pendopharm, Division of Pharmascience Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The implementation of a self-inspection program was inadequate.
3Other quality system
Documents were not available on the premises.
4Complaint and recall handling
The written procedures for recalls were inadequate.
5Other quality system
Complete testing was not performed according to the requirements.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-07. 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.
