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.
Get Up-To-Date COVID-19 Trade Resources
Latest Blog Posts
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 2020 – Is your OTC Drug Company Ready?
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to aid response efforts and ease the economic impact of COVID-19. In addition to COVID-19 response efforts, the CARES Act includes new reforms intended to...
Food Facility Registration to Require DUNS Number and Renewal Season Approaches
Beginning October 1, 2020, FDA will require a unique facility identification (UFI) number when registering food production facilities. Right now FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration. DUNS...
FDA Announces New and Updated Drug and Medical Device User Fees
FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with the newly established Over-the-Counter Monograph User Fee Program (OMUFA), enacted as part of the...
