Foreign manufacturers of regulated products who refuse to permit or delay FDA establishment inspection may be subjected to detention without physical examination (DWPE).

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.usfda.info/fda-detention/