Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated.
The electronic system was not validated for its intended use.
The implementation of a self-inspection program was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2024-11-18. 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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