Catalent Ontario Limited — Health Canada Inspection Findings

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging. The temperature and/or humidity control was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The recorded information or details were inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.

Validation studies were not conducted in keeping with the predefined protocols.

The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.

Water treatment plants and distribution systems were not designed, constructed, or maintained to ensure a reliable and adequate source of water. The preventative maintenance and repair of the equipment was inadequate.