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
Supreme Court Strikes Down Trump Part 2
What recommendations are you providing to your clients following the Supreme Court ruling on tariffs? We are advising our clients to file lawsuits in the Court of International Trade to recover tariffs paid. It's crucial to act swiftly to consolidate cases and...
Supreme Court Strikes Down Trump Part 1
What were the key events related to tariffs and Supreme Court rulings discussed in this episode? Trump initiated new tariffs on various countries' products, citing unfair trade practices and using the International Emergency Economic Powers Act (iEBA) to impose these...
Navigating FDA Imports and Compliance Risks
What is the statutory basis for the FDA's authority over imports and exports? The FDA's authority over imports and exports stems from the Food and Drug Cosmetic Act, which mandates the agency to ensure the safety, effectiveness, and wholesomeness of FDA-regulated...