Second FDA Audit at Exact Medical

Exact Medical Manufacturing, Inc. is pleased to announce the second successful FDA Audit of our facilities.

 

From March 28th through March 31st 2016, the US Food and Drug Administration performed a routine inspection audit at Exact Medical Manufacturing facilities in China.  We are pleased to report that there were no objectionable written observations and a FDA 483 form was not issued. We are even more pleased to inform that this is our second routine US Food and Drug Audit since our establishment in 2009 without any observations. Ryan Power, Vice President of Exact Medical states “These FDA Inspections reinforces and confirms our strict adherence to federal regulations as well as our own rigorous internal standards to ensure an industry leading quality driven production site.”

 

A Special thank you to all our team that leads the focus of quality driven production!