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Contact us today to learn how QA/RA Consulting Group can assist you.

U.S. Agent and FDA Official Correspondent

U.S. Agent

Foreign manufactures are required to maintain an office within the United States that acts as their U.S. Agent. This registration requirement applies to the following categories of foreign establishments:

  • Primary Manufacturers

  • Contract Manufacturers and Remanufacturers

  • Contract Sterilizers

  • Foreign Exporter of devices located in a foreign country

  • Specification Developers/Reprocessors of single use devices

US Agent Services Include:

  • Assist FDA in communication with the foreign manufacturer/ establishment.

  • Respond to questions from the FDA regarding the foreign establishment’s devices that are offered for import into the US.

  • Assist FDA in scheduling inspections of the foreign manufacturer.

FDA Official Correspondent

As a FDA registered Official Correspondent, QA/RA Consulting Group can provide additional services as your FDA liaison.

Services include all U.S. Agent Services as well as:

Contact us today to learn more about how QA/RA Consulting Group can assist you.
  • Annual registration and listing of the assigned establishment, which includes:

    • Creation of new registrations and listings

    • Cancellation of obsolete registrations and listings

    • Changes or updates to registration and listing information;

  • Adding establishment(s) to listings previously entered for the owner/operator.

  • Maintaining and submitting a current list of officers and directors to the FDA upon request.

  • Receiving pertinent correspondence from the FDA directed to and involving the owner/operator and any of the firm's establishments.