Kleinfeld, Kaplan & Becker assists companies with FDA import and export issues related to FDA-regulated products. We advise companies who have had entries held or detained by FDA when being offered for import into the US. We work with our clients and correspond with FDA compliance officers at the relevant ports of entry and with FDA’s Division of Import Operations to determine the reasons for any import detentions and to identify expedient ways forward. We counsel importers and manufacturers dealing with FDA-regulated products that are subject to Detention Without Physical Examination (DWPE) status under an FDA Import Alert. We assist clients in preparing and submitting petitions for removal from current FDA Import Alerts – either removal from an Import Alert’s “Red List” or addition to an Import Alert’s “Green List.”
Our firm also advises on compliance with the various import and export provisions of Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), such as the import for export (IFE) provisions and provisions regarding the export of investigational drugs and devices. We also assist clients in obtaining various export certificates, such as Certificates of Free Sale, Certificates to a Foreign Government, and Certificates of Exportability.