Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range. The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
The recorded information or details were inadequate. The procedures to identify the contents of each container were inadequate.
Evaluation of production processes, equipment, and/or materials was inadequate.
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Validation studies were not conducted in keeping with the predefined protocols.
Extracted automatically from the document of the Health Canada inspection on 2024-04-15. 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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