1Other quality system
Measures to ensure the compliance of the contracted test laboratories were inadequate.
Inspection Record
Provincial Health Authority - NL Health Services — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were 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.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Contamination control
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
8Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-03-23. 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.
