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 set appropriate alert and action limits for the results of particulate and microbiological monitoring.
The handling of standard operating procedures for good manufacturing practices 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 process was inadequate for the environmental classification of aseptic or clean areas.
Extracted automatically from the document of the Health Canada inspection on 2026-08-17. 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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