1Other quality system
The electronic system was not validated for its intended use. The controls put in place for electronic signatures were inadequate.
Inspection Record
Quadra Chemicals 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 or the content of the authentic certificate of analysis was inadequate.
3Other quality system
The recorded information or details were inadequate.
4Equipment and facility
"The maintenance of records was inadequate.
5Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
6Equipment 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. The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
7Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The temperature and/or humidity control was inadequate.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
10Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-07-26. 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.
