Respond to FDA Questions Regarding Establishment's Products
Assist FDA in Scheduling Inspections of the Establishment
FDA May Provide Information or Documents to the U.S. Agent (if Unable to Contact the Establishment)
FDA Official Correspondent
Responsible
FDA U.S. Agent
(Foreign Establishments)
Assist in Communications with FDA & Establishment
Respond to FDA Questions Regarding Establishment's Products
Assist FDA in Scheduling Inspections of the Establishment
FDA May Provide Information or Documents to the U.S. Agent (if Unable to Contact the Establishment)
FDA Official Correspondent
Responsible for Annual Establishment Registration and Device Listings.
Receive Correspondences from the FDA Involving the Owner/Operator and any of the Firm's Establishments
Updating the Facility Address, Deleting or Activating Device Listings, Adding Initial Importers and Managing the Account through FURLS (FDA’s Unified Registration and Listing System)