1Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Inspection Record
HK Kolmar Canada, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The operation of the water purification equipment was inadequate for ensuring a reliable source of water.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Equipment 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.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Equipment and facility
The recorded information or details were inadequate. The maintenance of records was inadequate.
10Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
11Material and supplier control
The temperature and/or humidity control was inadequate. The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.
12Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
13Laboratory and QC controls
The validation of test methods was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate. The design, equipment, and/or maintenance of the testing laboratory was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-06-09. 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.
