1Complaint and recall handling
The written procedures for recalls 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 implementation of a self-inspection program was inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. The handling of standard operating procedures for good manufacturing practices was inadequate.
4Stability and storage
The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
5Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
6Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Stability and storage
The ongoing stability program for a drug was inadequate. The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
9Other quality system
The master production documents were inadequate.
10Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
11Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-08. 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.
