Australia’s TGA Strikes Harder on Follow-up Inspections, CAPA Deficiencies

Device manufacturers operating in Australia will face more intense inspections if their CAPA plans fail to satisfy the Therapeutic Goods Administration after three tries following an inspection.

Jenny Hantzinikolas, director of the TGA’s Inspections, Manufacturing Quality Branch within the Medical Devices and Product Quality Division, said during a recent industry meeting that the agency had revamped its close-out process and that it would be taking a closer look at companies’ CAPA plans. Companies with recurring issues would get longer inspections, and the agency would request additional evidence.

During the 2016 to 2017 financial year, TGA inspectors closed out 95 percent of device inspections within their targeted timeframe.