U.S. FDA Resident Agent
Fratelli McNeese, keeping the complex simple and helping you attain and retain your place in the U.S. market.
Fratelli McNeese, Inc. is a consulting company specializing in assisting European exporters with U.S. Food and Drug Administration (FDA) resident agent, registration and compliance requirements. Here are three good reasons why Fratelli McNeese, Inc. is your ideal partner:
- We offer FDA and U.S. Customs know-how and experience.
- Our staff members studied and worked in both the USA and in Europe permitting us to offer our services in a multi-lingual and multi-cultural context (English-Italian-German-French).
- Staff members have working experience with the U.S. Government so we understand rules, regulations, and how the Government applies them.
We have experience in successfully serving the following industries: food, beverages, dietary supplements, medical devices and cosmetic products including fragrances.
How the FDA affects your business and how we facilitate complying with FDA requirements:
Foreign manufacturers that are subject to FDA facility registration requirements must also appoint a U.S. Agent for FDA purposes. The U.S. Agent acts as FDA’s primary point of contact for the foreign manufacturer. The foreign facility may also designate the U.S. Agent to act as its Official Correspondent with the FDA. Our clients choose us because they experience the benefits of having an FDA Resident Agent and Official Correspondent who is well-versed in FDA regulations and who can explain them in the client’s language and cultural context.
Responsibilities of a U.S. Agent:
As the FDA’s primary point of contact for the foreign manufacturer, it is important that the U.S. Agent understands how FDA regulates products being imported into the USA. According to the Food Safety Modernization Act (FSMA), the FDA must inspect overseas facilities exporting to the USA; and therefore, it is important that the U.S. Agent comprehends the manufacturing process regulations that the foreign manufacturer must satisfy. Fratelli McNeese collaborates with McNeese Customs & Commerce srl in Europe to provide on-site, personalized training in FDA Current Good Manufacturing Practices (CGMPs) to foreign manufacturers. Fratelli McNeese clients may elect to have our European partner present during FDA inspections to bridge cultural and linguistic barriers.
Many U.S. Resident Agents sell U.S. Agency and facility registration services. Although they may also provide some basic regulatory assistance, many lack substantial experience in FDA regulations and procedures to help you identify, prevent and apply rapid and lasting solutions to potential compliance problems. Fratelli McNeese, Inc. believes you should select a U.S. Agent based on their qualifications, experience, and ability to provide comprehensive regulatory compliance services starting from the manufacturing process to marketing (including product claims) to product importation into the USA.
The need for dual FDA – CBP compliance:
U.S. Customs and Border Protection (CBP) has a general primary responsibility for regulating international trade with the USA and for enforcing United States trade laws. Information must be filed with CBP for all goods imported into the United States. CBP collaborates with other Partner Government Agencies (PGAs) having jurisdiction over specific products entering the USA.
If the article being imported falls under FDA’s jurisdiction, it is subject to FDA review. Section 801(a) of the Federal Food, Drug, and Cosmetic Act provides for examination of imports and also authorizes FDA to refuse admission of imports that appear, from examination or otherwise, to violate FDA requirements.
For these reasons, Fratelli McNeese has a Licensed U.S. Customhouse Broker on staff with extensive FDA experience to help our clients comply with both U.S. Customs laws and FDA laws prior to and during the export-import process.
Our primary business value for you:
We offer a multi-disciplinary, multi-lingual and multi-cultural approach that makes the complex simple and easy to understand .
Contact us at email@example.com