1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
SV Labs Toronto Corporation — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Evaluation of production processes, equipment, and/or materials was inadequate. The master production documents were inadequate. The annual product quality review procedure was inadequate.
3Material and supplier control
Specific identity testing was not conducted on all lots of raw materials received on the premises.
4Other quality system
The working spaces were inadequate. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
5Equipment and facility
The operation of the water purification equipment was inadequate for ensuring a reliable source of water. The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
6Deviation, CAPA, and investigation
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. Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-07-21. 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.
