1Other quality system
The master production documents were inadequate.
Inspection Record
Ostrem Chemical Co. Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Other quality system
The assessment to release finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-05. 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.
