Imported FDA-regulated products are required to comply with a myriad of rules and regulations specific to the product being imported. Products that are detained may be released once the appearance of a violation is overcome.
Fuerst Humphrey Ittleman has the in-depth knowledge to help companies avoid detentions by the Food and Drug Administration, as well as managing detained products to ensure they enter the US in compliance with both federal and state laws.
The failure to demonstrate to the FDA that a detained product is in fact in compliance generally leads to an FDA refusal within 10 days of any FDA detention. Once an FDA refusal issues, an importer must export or destroy the products.
Products are refused for many reasons including an existing Import Alert. In certain circumstances, there may be administrative solutions to rescind a refusal if the evidentiary basis for the refusal is flawed.
Before importing an FDA product, importers can determine whether a specific shipper or product is subject to automatic detention. This can be done online by reviewing the most current Import Alerts recorded on the FDA's website:
http://www.fda.gov/ora/fiars/ora_import_alerts.html
For more information, please contact Christine M. Humphrey, Esq. at chumphrey@fuerstlaw.com.
