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.
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Latest Blog Posts
Pet Food Processors – Additional Enforcement Looming
The Food & Drug Administration (FDA) has begun to apply Import Alert 99-29, "Detention Without Physical Examination of All Vegetable Protein Products From China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs," to imported...
Registration Season is Coming! FDA has announced the Medical Device User Fees for Fiscal Year 2022
FDA has officially announced the updated medical device fees for the 2022 fiscal year (October 1, 2021 – September 30, 2022). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait...
US Senators Introduce Bipartisan Legislation to Require Manufacturers of ENDS Products to Pay User Fees
On Friday, July 23rd, a bipartisan group of Senators introduced legislation that, if enacted, would require the manufacturers of e-cigarettes, vaping products, and other forms of electronic nicotine delivery systems (ENDS) to pay annual user fees to the Food and Drug...
