Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
The ongoing stability program for a drug was inadequate.
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2023-12-04. 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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