1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Confab Laboratories, Inc. — 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.
3Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Material and supplier control
The protection of products and/or materials from contamination 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.
7Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
8Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
9Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-09-03. 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.
