The quality control department's handling of complaints and/or information received about drug quality was inadequate.
Inspection Record
Chiesi Canada Corp. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The ongoing stability program for a drug was inadequate. The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-04-01. 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.
