Edesia WorldWide U.S. Agent Service

To register, NON-U.S. food facilities must designate a U.S. agent for FDA communications.

All registered non-U.S. food facilities must designate a U.S. Agent for FDA communications. The U.S. Agent serves a different function than your importer, customs broker, commercial distributor, or trade association. For example, importers acting as your U.S. Agent could make mistakes that may affect your ability to ship to the United States. FDA communicates through the U.S. Agent to schedule inspections and to alert you of other FDA matters.

Edesia WorldWideU.S. Agent service includes:

  • Registration Renewal: Mandatory Biennial FDA Food Facility Registration Renewal
  • Certificate of Registration: Certificates issued by Registrar Corp provide confirmation of your facility’s registration to industry
  • Registration Updates: Registrations must be updated within 60 days of a change in required information
  • Prior Notice: Three free Prior Notice filings each year for your exports to the USA
  • Detention Assistance: Communication with FDA on your behalf to seek the release of a detained shipment
  • Mock FDA Inspection: Onsite expert assistance at no charge except travel and lodging for a scheduled FDA inspection
  • DUNS Assistance: Obtain a DUNS number or update an existing DUNS record
  • FDA Compliance Monitoring: A unique system that continuously monitors your company’s FDA compliance status

 

CONTACT US FOR YOUR SPECIFIC NEEDS

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U.S. FDA Food Registration and U.S. Agent Requirements

U.S. FDA CITATION: 21 C.F.R. SECTIONS 1.225 – 1.243U.S.
FDA food facility registration is required for all facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States. Facilities located outside the United States must also designate a U.S. Agent for FDA communications.

Food facility registration with U.S. FDA

For NEW food facility registrations with U.S. FDA

Edesia WorldWide Regulatory Specialist will register your facility with FDA and mail you a Certificate of Registration issued by Edesia WorldWide.

For facilities located outside the United States, Edesia WorldWide will also act as your U.S. Agent for FDA Communications.


Services

FOOD AND BEVERAGES

The U.S. FDA regulates food and beverages  intended for consumption in the United States by humans or animals.

Edesia WorldWide, LLC provides Registration, U.S. Agent, and Regulatory Compliance Assistance for Italian Companies in the food and beverage.

FDA REGISTRATION AND U.S. AGENT REQUIREMENTS

U.S. FDA registration is required for all facilities that manufacture, process, pack, or store food and beverages that may be consumed in the United States by humans or animals.

Companies located outside the United States of America must designate a U.S. Agent for U.S. FDA communications.


Logistic

 Logistic

Siamo in grado di organizzare la logistica per prodotti alimentari surgelati, freschi e secchi in tutti gli Stati americani, grazie alle partnerships con i più importanti distributori.

 


Import in USA

The U.S. market is the most important export market for European companies and is extremely interesting for a number of reasons:

  • The US economy is now growing again, made up of over 310 million inhabitants with a medium-high GDP per capita.
  • The political system is stable and attentive to the needs of both startups and existing companies
  • the label “Made in EU” for Americans is synonymous with quality, history, and culture; for example, Made in Italy is always appreciated, even in areas which are not strictly consumer goods, such as machinery and related technology.
  • The American bureaucracy has clear and simple rules, it’s transparent, doesn’t hinder development but instead is at the service of businesses, and provides quick answers regarding any authorizations or permits.
  • There are real incentives (tax credits, low cost loans, etc) to companies that invest and hire local staff
  • The cost of energy is minor compared to that of Italy and Europe.
  • The labor market is flexible, built on meritocracy and growing your business.
  • The resolution of litigation between companies is quick. Corruption and extortion are virtually absent
 Being successful in the USA means selling even more in other countries: many buyers (South American, Asian and even European) collect information in the U.S. to purchase products for their companies outside the U.S.

The above considerations make the U.S. market attractive for all companies in the world and also the most competitive; it is therefore a necessary first step to study the entry strategy through a detailed market research analysis and solid business plan.