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.
Facility Registration & Listing
Register your food facility, medical device facility, or drug facility with the FDA.
Claims Substantiation
Avoid costly mistakes by ensuring that your product claims are properly substantiated.
Import Alerts
Get your firm removed from FDA Import Alerts—and stay off them for good.
Holds & Detentions
Rescue your shipments from FDA detentions and move them back into the U.S. market.
SOPs / Quality Controls
Ensure that your manufacturing practices are in full compliance with the law.
Recalls
Learn the different types of FDA product recalls, as well as common causes and pitfalls.
Other Services
Get help with food, drug, dietary supplement, cosmetic, or medical device services.
Latest News
Understanding Voluntary Disclosures in FDA and Customs
What are the circumstances where a company is obligated to tell the government about safety-related issues related to their products according to the Food and Drug Administration (FDA)? Companies are obligated to report safety-related issues to the FDA when there is a...
Customs Post-Entry Audits Explained: CF-28s, CF-29s, and What Happens After Clearance
Why isn't a shipment fully cleared once it passes through customs? When a shipment enters the United States, it is initially released to the importer on a conditional basis. This means that while the goods may be in the importer's possession, the release is not final....
First FDA-Regulated Import? The Mistakes That Get Shipments Stopped
What are the common starting problems for companies importing FDA-regulated products for the first time? Problems often begin at the inception of the transaction between the importer and the foreign supplier. Many issues arise from the purchase order stage, where...