Inspection Record
View the regulator's official source The source document is always the basis for judgement.
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate. The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination. The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products.
Evaluation of production processes, equipment, and/or materials was 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 investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
The drug fabricator's specifications for raw materials were inadequate. The test methods were not validated and/or the results were not documented. The sampling plan for raw materials was inadequate.
The protection of products and/or materials from contamination was inadequate.
The company's visual inspection of filled containers was inadequate.
The operators'aseptic practices were inadequate to maintain sterility.
The documentation for the integrity testing of sterilizing filters was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2024-01-16. 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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