FDA AGENTS
John Balstreri, Managing Director
As Managing Director, it is my privilege to direct FDA Agents in helping companies worldwide do business in the USA. My experience as a lawyer helps our clients with professional service as US Agent, in responding quickly, thoroughly and personally to your inquiries and needs. We provide prompt, efficient and personal service to you in complying with the registration requirements of the US FDA.
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- Registers your domestic (US) or foreign (non-US) food or medical device facility with the FDA and advises you of the mandatory FDA Registration Number, and
- Serves as your mandatory U.S. Agent required for foreign food or medical device facilities under the laws and serves you confidentially.
For FOOD and BEVERAGE and WINE companies, simply click "REGISTER FOOD" here or the "REGISTER NOW" button on the left.
For MEDICAL DEVICE COMPANIES, the mandatory ESTABLISHMENT REGISTRATION and MEDICAL DEVICE LISTING with the US FDA for Class I and Class II exempt devices can be completed here. To start the process and complete the registration and listing forms, just click "REGISTER MEDICAL" here or in the menu above.
If you have any questions, simply send us an email to info@fdaagents.com
YES! You must register with the FDA and have a US Agent. Without your FDA Registration Number, your products will not be allowed into the USA and you are subject to civil and/or criminal liabilities. The US FDA has the power to enforce the criminal and money penalties.
FDA Final Rules state: "FDA has determined that it will contact the foreign facility's U.S. Agent when an emergency occurs..." FDA Agents, Inc. is an independent U.S. Agent, which means that others such as your competitors or importers do not become aware of what the FDA might be saying to you or asking you.
FDA Agents, Inc. is an expert in FDA registration. We register foreign and domestic Food or Medical Device Facilities with the FDA and serve as the U.S. Agent for foreign food or medical device facilities. Our Internet (electronic) registration system is available 24 hours a day, 7 days a week. Working with our attorney and translators, FDA Agents, Inc. is a private company highly qualified to register your Domestic or Foreign Food or Medical Device Facility and serve as your required U.S. Agent for Foreign Food Facilities and foreign Medical Device Facilities, in compliance with FDA regulations.
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WHAT WE DO
FDA AGENTS, INC. GETS YOU INTO COMPLIANCE WITH THE LAW SO YOUR PRODUCTS CAN ENTER THE USA
- FDA Agents, Inc. handles FDA registrations: we register your food or medical device facility with the FDA and advise of your mandatory FDA Registration Number;
- FDA Agents, Inc. serves as your mandatory "U.S. Agent" for foreign food or medical device facilities; ("U.S. Agent" is not the same as the agent for customs or other import purposes; it is specific in the new regulations and refers to a different person/company with different duties and responsibilities) Read the Definitions
- FDA Agents, Inc. translates the registration questionnaire into your native language and translates it back into english for the FDA, as english is required by the FDA;
- FDA Agents, Inc. interacts between the FDA and you as your U.S. Agent for all alerts, notices and communications to comply with the Boterrorism Act;
- FDA Agents, Inc. CONFIDENTIALLY transmits all legally required notices and communications between the FDA and your food facility;
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PROTECT YOUR
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By studying this site: Read the FDA Registration Laws Register and appoint FDA Agents, Inc. as your U.S. Agent. These laws are complex. If you fail to comply, your products will be denied entry into the U.S. and will be held at the port of entry at your expense until you do comply. Comply now, because without your FDA Registration Number, your shipments will not be allowed entry into the USA.
** FDA Agents, Inc. is a private company, not a part of, or affiliated with, the United States Government or the Food and Drug Administration.**
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