Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The handling of standard operating procedures for good manufacturing practices was inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Validation studies were not conducted in keeping with the predefined protocols.
Extracted automatically from the document of the Health Canada inspection on 2025-12-01. 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.
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