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The Way Through

Proven experience for complete, efficient results every time

Importing food, beverages, cosmetics, medicines, and medical devices into the highly-regulated markets of the United States can be confusing, complex, and costly. This is particularly true if you do not have an experienced team of professionals to give you confidence that your products and your facilities meet all applicable federal & state regulatory requirements. Do not guess about which U.S. FDA regulations apply. Do not wonder or worry whether your products, packaging or labels comply with all FDA requirements before shipping them to the United States. Read More//

FDAIMPORTS.COM IS A PRIVATE COMPANY, AND IS IN NO WAY AFFILIATED OR ASSOCIATED WITH, OR ENDORSED OR APPROVED BY, THE UNITED STATES FOOD AND DRUG ADMINISTRATION.

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FDA NEWS & BLOGS

COVID-19 CONTINUITY OF SERVICE

Navigating NewTariffs

FDA REGISTRATION AND LISTING

FDA IMPORT ALERTS & DETENTIONS

FDA LABEL REVIEW & DESIGN

COVID-19 Resources for Life Sciences and Other Goods

As part of our response to the COVID-19 crisis, we have gathered resources for the import, manufacturing, logistics, and trade community.......
Warning About Face Mask Imports

Over recent days and weeks we have seen a significant increase in counterfeit or fraudulent respirators/face masks and certificates. Understandably, people want to get as many medical face masks to market as possible,......
FDA Expands EUA to Include more Imported Disposable Face Masks

On March 24, 2020, FDA issued guidance extending an Emergency Use Authorization (EUA) to "Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFR) that have been validated to meet specific performance standards or have a marketing authorization in certain countries."......
GAO Study on FDA’s Seafood Import Alerts Released

The U.S. Government Accountability Office recently issued a report that reviewed the steps FDA takes when removing seafood products from import alert...
Hand Sanitizers:FDA Issues Final Rule

Effective April 13, 2020, this final rule applies to a variety of consumer antiseptic products, including "rubs, leave-on products, or hand "sanitizers," as well as consumer antiseptic wipes," that are intended to be used without water......

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.