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 company did not monitor the aseptic filling area frequently enough to avoid possible contamination or system deterioration.
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The temperature and/or humidity control was inadequate.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
The ongoing stability program for a drug was inadequate.
The annual product quality review procedure was inadequate.
The company used sample retention sites outside of Canada without sending a request to Health Canada.
The evidence required to demonstrate compliance with finished product specifications 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 2023-02-06. 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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