1Quality unit oversight
The annual product quality review procedure was inadequate.
Inspection Record
Delta Plus Canada 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 written procedures and records for retaining samples were inadequate.
3Material 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. The company did not test the effectiveness of antimicrobial preservatives for a drug before it was marketed and/or at the end of its proposed shelf life.
4Stability and storage
The ongoing stability program for a drug was inadequate.
5Other quality system
The assessment to release finished products was inadequate.
6Laboratory and QC controls
Test methods were not validated or the method transfer studies were not conducted.
7Other quality system
Documents were not available on the premises. The recorded information or details were inadequate.
8Regulatory 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 2023-08-09. 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.
