1Equipment and facility
The maintenance of records was inadequate.
Inspection Record
B. Braun Medical 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 environmental sampling methods were inadequate.
3Other quality system
The company's visual inspection of filled containers was inadequate.
4Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-20. 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.
