1Aseptic processing and sterility assurance
The company did not take precautions to minimize contamination during all processing prior to sterilization.
Inspection Record
AbbVie 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 electronic system was not validated for its intended use.
3Aseptic processing and sterility assurance
The environmental standards were inadequate in order to minimise particular or microbial contamination of aseptic or clean areas.
4Other quality system
The company's visual inspection of filled containers was inadequate.
5Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-13. 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.
