Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
The company's cleaning of the premises and the equipment in aseptic areas was inadequate. The operators'aseptic practices were inadequate to maintain sterility.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
The labelling of outlets for liquids and/or gases was inadequate.
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
The recorded information or details were inadequate.
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Evaluation of production processes, equipment, and/or materials was inadequate.
The availability, implementation, and/or quality of the written sanitation program was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2024-01-22. 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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