U.S. Agent Annual Service
Each foreign establishment involved in processes of manufacturing, preparing, commercializing and warehousing food andbeverage products, medical devices and drugs in the United States must identify an U.S. Agent as delegating company.
It’s very important to identify an U.S. Agent different from the local distributor in order to be independent and to avoid any contention with this last one.
BYM! is willing to render its service as your U.S. Agent in accordance with FDA requirements of chapter 21 CFR 807.40.
For example, as your U.S. Agent, we can:
- support you with your correspondence with FDA and vice versa;
- respond on your behalf in case of FDA requests about foreign products imported and commercialized in the United
- act as your contact and recipient of information and documents by FDA.