CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements

Regulatory NewsRegulatory News | 26 January 2016 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements.

TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with a polypropylene tape, fixed internally alongside the ligament and precisely tensioned using minimally invasive surgery.”

Although FDA does not list the company’s specific quality system deficiencies, TFS, which has yet to respond to a request for comment from Focus, joins more than 130 foreign companies on the list from more than 25 different countries.

“Foreign inspections of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's),” FDA says. “DWPE may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveal conditions or practices warranting detention of either particular products or all products manufactured by a firm.”

The import alert on TFS and all other firms the list will remain in effect until FDA is satisfied that the appearance of a violation has been removed, either by re-inspection or submission of appropriate documentation.

So far this year, FDA has added three companies to the list, including China’s Xiantao Tongda Non-woven Products Co. and Taiwan’s E-Care Technology.

Import Alert List




© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy