1Equipment and facility
The maintenance of records was inadequate.
Inspection Record
ZO Skin Health Canada ULC — 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.
3Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
4Laboratory and QC controls
The product was made available for sale without the approval of the quality control department. The quality control department did not undertake all of the required activities.
5Other quality system
The assessment to release finished products was inadequate.
6Computer system validation
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The computerized system used to manage product inventory and distribution records to support recalls was not validated.
7Stability and storage
The temperature and/or humidity control was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-09. 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.
