Willow Glen Consultancy LLC

Willow Glen FDA registration & certification

FDA US Agent

Any outside foundation occupied with the assembling, readiness, spread, aggravating, or preparing of a gadget brought into the United States must distinguish a United States operator (U.S. agent) for that foundation.

FDA certificate of registration

Data about an outside foundation's FDA US Agent is submitted electronically utilizing the FDA Unified Registration and Listing System (FURLS framework) and is a piece of the foundation enrollment process. Each outside foundation may assign only one U.S. specialist. The outside foundation may likewise, yet isn't required to, assign its U.S. operator as its official reporter. The remote foundation ought to give the name, address, phone and fax numbers, and email address of the U.S. specialist.

The U.S. agent recognized will be required to finish a mechanized procedure to affirm that they have consented to go about as the U.S. operator. The mechanized procedure will advance an email confirmation solicitation to the U.S. specialist. They will be mentioned to affirm her/his agree to go about as an agent/contact in the interest of the remote foundation. In the event that the U.S. specialist denies assent (or doesn't react inside 10 business days), the Official Correspondent/Owner Operator of the remote foundation will be advised and should assign another U.S. specialist to fulfill the administrative commitment.

Duties of a U.S. agent

The U.S. agent should either live in the U.S. or then again keep up a position of business in the U.S. The U.S. agent can't utilize a mail station box as a location. The U.S. agent can't utilize only a replying mail. They should be accessible to pick up the telephone or have a representative accessible to pick up the telephone during typical business hours.

The obligations of the U.S. specialist are restricted and include:

-Helping FDA in correspondences with the remote foundation.

-Replies to questions concerning the remote foundation's devices that are imported or offered for import into the United States.

Address: 3755 Avocado Blvd, # 208, La Mesa, CA 91941, USA

Phone: +1-619-869-0249 Fax: +1-619-839-0345

E-mail: [email protected]