Jubilant Generics Limited — Health Canada Inspection Findings

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 preventative maintenance and repair of the equipment was inadequate.

The annual product quality review procedure was inadequate.

The evidence required to demonstrate compliance with finished product specifications was inadequate.

The master production documents were inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The design, equipment, and/or maintenance of the testing laboratory was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate.