Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The process was inadequate for the environmental classification of aseptic or clean areas.
The maintenance of records was inadequate.
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2024-03-25. 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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