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
FDA Compliance Won’t Protect You From CBP Enforcement
Why is FDA approval not enough to avoid customs issues for import shipments? FDA compliance alone may not safeguard shipments from customs issues because customs jurisdiction covers everything crossing the border, including technical requirements unrelated to FDA...
Tariff Refunds Are Triggering New Customs Audits
Why are tariff refunds creating deeper scrutiny for importers now? Tariff refunds have become a significant issue as customs lost a Supreme Court case regarding the IEPA tariffs. The court ordered refunds, but not all importers were part of the lawsuit. Customs has...
Registration Season is Coming! FDA has announced the Medical Device User Fees for Fiscal Year 2027
On July 30, 2026, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year 2027 (FY 2027), effective October 1, 2026, through September 30, 2027. All...