1Laboratory and QC controls
The quality control department did not undertake all of the required activities.
Inspection Record
PLZ Corp. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Equipment 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 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).
5Other quality system
Periodic confirmatory testing was not conducted.
6Laboratory and QC controls
The duties of the individual in charge of the quality control department were delegated to an unqualified individual.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-08-12. 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.
