Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The availability, implementation, and/or quality of the written sanitation program was inadequate. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
The recorded information or details were inadequate.
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
The stability program did not include batches of drugs that had been stored for extended periods of time before they were packaged.
Extracted automatically from the document of the Health Canada inspection on 2021-03-29. 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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