US Agent & Official Correspondent

When preparing to initiate establishment registration using the FDA Unified Registration and Listing System (FURLS), allow Compliance Insight, Inc. to assist you by assigning us as your FDA U.S. Agent and/or FDA Official Correspondent.

FDA US Agent

U.S. agents are required by any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States. According to FDA, the U.S. agent:

  • Must either reside in the United States or maintain a place of business in the United States,
  • Cannot use a post office box as an address,
  • Cannot use just an answering service; they must be able to answer the phone or have an employee available to answer the phone during normal business hours.

As your U.S. Agent, Compliance Insight, Inc. will provide you with the following services:

  • Coordinate FDA communications,
  • Provide answers to questions concerning your devices that are imported or offered for import into the United States,
  • Schedule inspections of your establishment,
  • Receive information and documents from the FDA on your behalf, if necessary.

FDA Official Correspondent

Each establishment requires an official correspondent be designated as the primary point of contact for FDA on matters relating to the registration of drug or device establishments and the listing of products. As your Official Correspondent, Compliance Insight, Inc. will:

  • Maintain your electronic registration and listing,
  • Receive important and time-sensitive FDA correspondence on your behalf, and
  • Keep FDA updated on necessary company knowledge.

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical¬†Development

  • Nonclinical Development

  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design

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