Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate. The master formula for packaged products did not include the required information. The recorded information or details were inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
Evaluation of production processes, equipment, and/or materials was inadequate.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2025-01-20. 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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