1Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
Inspection Record
Cellchem Pharmaceuticals Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Laboratory and QC controls
There was no evidence of a functioning and/or independent quality control department. The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
4Stability 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 .
5Material and supplier control
The company did not determine the stability of the drug before it was marketed or before significant changes were made to the drug formulations, fabrication procedures, or packaging materials.
6Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
9Other quality system
Critical production processes were not validated.
10Regulatory reporting and change control
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 2021-08-03. 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.
