1Other quality system
The controls put in place for electronic signatures were inadequate.
Inspection Record
Pharma Stulln Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The importer did not have a batch certificate for each lot or batch of the drug received.
3Other quality system
Documents were not available on the premises. The master production documents were inadequate.
4Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-05-29. 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.
