1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Teva Canada Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance and repair of the equipment was inadequate.
3Material and supplier control
The protection of products and/or materials from contamination was inadequate.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-03-04. 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.
