1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
CHX Technologies Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment 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.
3Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
4Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
5Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale. The ongoing stability program for a drug was inadequate.
6Laboratory and QC controls
The controls put in place for electronic signatures were inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-03. 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.
