1Other quality system
The controls put in place for electronic signatures were inadequate.
Inspection Record
Barentz Canada ULC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Laboratory and QC controls
The product was made available for sale without the approval of the quality control department. The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Quality unit oversight
The annual product quality review procedure was inadequate. The quality control department did not evaluate the results of the annual product quality review.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-06-10. 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.
