FDA Consultants & Advocates

Get targeted help with FDA/USDA compliance so you can move your products with confidence.

Serving Companies Worldwide

At FDAImports, we solve the problems involved in bringing products to the highly regulated U.S. market. Our team has over 100 years of direct FDA experience, helping manufacturers, distributors, importers and exporters of regulated products navigate the regulatory maze and successfully enter and stay in U.S. markets.

Solutions for Every Business

Label Reviews

Ask an expert to check your product labels for regulatory compliance.

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Facility Registration & Listing

Register your food facility, medical device facility, or drug facility with the FDA.

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Claims Substantiation

Avoid costly mistakes by ensuring that your product claims are properly substantiated.

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Import Alerts

Get your firm removed from FDA Import Alerts—and stay off them for good. 

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Holds & Detentions

Rescue your shipments from FDA detentions and move them back into the U.S. market.

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SOPs / Quality Controls

Ensure that your manufacturing practices are in full compliance with the law.

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Recalls

Learn the different types of FDA product recalls, as well as common causes and pitfalls.

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FDAImports--Other Services

Other Services

Get help with  food, drug, dietary supplement, cosmetic, or medical device services.

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Latest Blog Posts

FDA Updates Drug Reporting Requirements

FDA Updates Drug Reporting Requirements

On February 5, 2024, FDA issued a final guidance regarding reporting by drug establishments for listed drug and biological products manufactured, prepared, propagated, compounded, or processed for commercial distribution. The upshot is that drugs listed with FDA must...

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