We help companies around the world comply with the following :
Food Safety Modernization Act (FSMA)Federal Food Drug and Cosmetic Act (FD&C Act) Dietary Supplement Health and Education Act (DSHEA)
More than 449,859 facilities from 223 countries and territories
are registered with the FDA, including 22 countries with at least 3,000 registrations each.
The FDA oversees more than 36.9 million shipments of
regulated products from over 150 nations, handled by 130,000 importers
and manufactured, processed, or packaged
at more than 300,000 foreign facilities.
Some companies avoid FDA REGISTRATION until their shipment is DENIED ENTRY by the U. S. Customs and Border Protection (CBP), or they have to deal with FDA detention without physical examination (DWPE). Not recommended
Do you know whether or not your company is on the FDA's Green List or Red List? Any idea what that means?
FDA detention without physical examination - DWPE. Sounds familiar?
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent for that establishment.