C.HUMPHREY & ASSOCIATES P.A.

Our FDA Lawyers Help You Avoid Detention, Save Money

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. Our import attorneys have the in depth knowledge to help our clients avoid FDA detentions and manage detained products to ensure that the products enter the U.S. in compliance with federal and state laws.

The failure to demonstrate to the FDA that a detained product is 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 by viewing the most current Import Alerts at

http://www.fda.gov/ora/fiars/ora_import_alerts.html

Other helpful links