U.S. Agent for FDA Communications: Why Registrar Corp?

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Companies located outside the USA are required to designate a U.S. Agent for FDA communications. Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA, is expanding the U.S. Agent service it offers to foreign companies.

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U.S. Agent clients will now enjoy benefits such as registration renewal, mock facility inspections, and more

Registrar Corp is expanding its U.S. Agent service for foreign companies. Registrar Corp’s U.S. Agent clients will now enjoy benefits such as registration renewal, mock facility inspections, and more. When registering with the U.S. Food and Drug Administration (FDA), foreign food facilities are required to list a U.S. Agent for FDA communications. The U.S. Agent is expected to be available for FDA to contact 24/7 and is responsible for facilitating communication between FDA and the foreign food facility, answering FDA’s questions about specific shipments, and assisting FDA in scheduling inspections of the foreign facility. The U.S. Agent must have a place of business or residence and be physically present in the United States.

The function of a U.S. Agent is very different from that of an importer or customs broker; therefore, it’s important to designate a U.S. Agent with experience and expertise in FDA regulations. There are many benefits of designating Registrar Corp as a U.S. Agent:

Registrar Corp is experienced, multilingual, and always available

Registrar Corp has been helping companies comply with FDA regulations since 2003 and currently acts as a reliable U.S. Agent for over 10,000 companies around the world. Registrar Corp’s U.S. staff is multilingual, so clients rarely have to worry about language barriers. The firm also has 17 other offices around the world to offer specialized assistance. Registrar Corp Regulatory Advisors are available 24 hours a day for both FDA and clients to contact.

Registrar Corp will update and renew its clients’ FDA registrations

If any information submitted to FDA in a food facility registration changes, the responsible party has 60 days to update the information in FDA’s registration database. Along with updates, FDA requires food facilities to renew their registrations between October 1 and December 31 of each even-numbered year. Registrar Corp will submit any necessary updates on behalf of its U.S. Agent clients, as well as biennially renew their registrations, at no extra cost.

Registrar Corp will help its client prepare for an FDA inspection

When a facility registers with FDA, it gives FDA permission to inspect the facility. Registrar Corp helps its clients communicate with FDA before and after the inspection and assists clients in preparing for the inspection. Registrar Corp will even send a food safety expert trained in FDA inspections to its client’s facility to perform a mock inspection. If FDA sets a specific inspection date, this mock inspection service is offered at no additional charge other than travel and lodging expenses.

Registrar Corp assists with detentions

If a client’s product is detained by FDA, whether during the import process or an inspection, Registrar Corp will communicate with FDA to seek release of the shipment and guide the client through the necessary steps.

Registrar Corp’s U.S. Agent service includes three free prior notice filings

A foreign facility must submit prior notice to FDA for every shipment it sends to the United States. Facilities can quickly file prior notice with FDA via fax or online using Registrar Corp’s Prior Notice Express. Registrar Corp’s U.S. Agent clients receive three complimentary prior notice filings each year.

Foreign facilities can change their U.S. Agent at any time. Designate Registrar Corp as your U.S. Agent now and take advantage of all the benefits the firm has to offer. For more information on U.S. FDA requirements for food facilities, or to learn more about Registrar Corp’s U.S. Agent service, contact Registrar Corp at 1-757-224-0177 or chat with a Regulatory Advisor anytime using the Live Help service: http://www.registrarcorp.com/livehelp.

About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 18 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations

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David Lennarz

Liviana Callahan
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