FDA Import Refusal and Detention

Inspection refusals and detentions often lead to valuable shipments being rejected, re-exported and/or refused. We can help intervene to ensure all the facts are presented before its too late.

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FDA Registration

Registration for Every Facility Type, Foreign and Domestic. Professional team coupled with a legal (label, ingredient approval etc.) review of every registration.

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FDA Approval

Whether you need medical device approval (510(k), Class I Exempt, or PMA), drug approval (OTC, homeopathic), food or dietary ingredient approval, or cosmetic approval we can help.

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Complimentary Consultation

Questions about how the FDA regulates your business or new invention? Concerned about a recent FDA or USDA, FNS enforcement action? Please contact our D.C. or Charlotte offices for a complimentary consultation.

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FDA Attorney in Washington D.C. and Research Triangle NC

Looking for an FDA Attorney in Washington D.C.?

FDA Atty is a boutique law firm solely specializing in FDA laws and regulations. We are based out of Washington D.C. and Charlotte, NC, but serve clients around the world. Our FDA attorneys and consultants carry a depth of experience working on FDA approval and enforcement. Our firm can answer your questions on FDA approval pathways and registrations for dietary supplements, medical devices (Class I, II, and III) and various drug products (NDA, OTC, Homeopathic), cosmetics and tobacco products (e-cigarettes, vapes, e-liquids). If you are the subject of an FDA enforcement action (recall, warning letter, 483, import refusal or inspection), then our FDA attorneys can intervene to ensure a fair resolution to your case.

Our FDA Attorneys represent companies, and corporations that are FDA regulated. We have worked with companies from around the world in importing different products such as: animal feed and drugs, food, beverages, cosmetics, medical devices, dietary supplements, acidified foods and OTC drugs. Our attorneys bring extensive experience in the areas of food and dietary supplement safety, labeling and advertising claims, including health claims, qualified health claims, structure/function claims, and nutrient content claims.

Our services include opinion letters regarding the status of food ingredients in the United States, preparing food additive petitions, GRAS notifications, and new dietary ingredient notifications. Whether its international compliance, distribution agreements, USDA, FNS/SNAP, APHIS, or litigation expert call for a complimentary consultation.

If you import medical devices, drug products, pharmaceuticals, cosmetics, or even tobacco products we can help you register your product properly. We work with large international companies, and small business owners. We only practice FDA law; giving you the best, most specialized service when it comes to FDA law. Whatever your FDA need is, we are ready to give our experience and expertise; so call us now!


How Can We Help You?

Simply need to register your facility, list your medical device, obtain a NDC relabler code, or other registration activity? We can help and offer a number of registration certificates.

Confronted with a 483, warning letter, import detention order or alert, or need immediate assistance during an FDA inspection? Contact us at 202.765.4491.

From farm to fork we can guide you on FDA and USDA regulations. Whether its introducing a new ingredient, importing a product, requesting an Export Certificate, or starting a new food company we can provide you the right guidance on all FDA food regulations.

Medical device regulations can be dizzying. From enforcement matters to entering the market we can guide you. We can help with Device Classification, Registration, export agreements, and more.

Natural remedies to everyday vitamins, we offer a broad range of service to the dietary supplement industry.

OTC Drug and cosmetic regulations can be difficult to navigate. We can help you find the most efficient route to market, review your label, and more. We also work with doctors caught in a FDA criminal investigation into counterfeit drug products.

New tobacco products, e-cigarettes and vape products all pose conflicting and confusing issues. We can help with the pre-market requirements and clarify the requirements. Our firm can also help you respond to a FDA Tobacco Retailer Warning Letter.

We love our pets and want to ensure their food and medicine is safe and trusted by consumers. From animal feed, to pet treats, and medical devices the FDA covers it all. So do we.

Foreign manufacturers and exporters are required to identify and list a U.S. Agent when registering their facility. Our firm acts as U.S. Agent for medical device, food, dietary supplement and drug companies across the world.