Guia De Exportacion A Usa

Regulatory Procedures Manual March 2010

Chapter 9 Import Operations And Actions

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Chapter 9 IMPORT OPERATIONS AND ACTIONS
Note: Chapter 9 (Rev. 2002) is currently under revision. Editorial revisions made by DIOP in January 2008. This chapter includes the following sections: Section Topic _____Page 9-1 ImportProcedures ............................................................................................... 9-1 9-2 Coverage of Personal Importations.................................................................... 9-12 9-3 Importation of Biological Products...................................................................... 9-15 9-4 FDA National Import Procedure Regarding Warehouse Entries........................ 9-15 9-5 Release Notices................................................................................................. 9-16 9-6 Detention without Physical Examination (DWPE) .............................................. 9-18 9-7 Notice of Detention and Hearing ........................................................................ 9-30 9-8 Response (Hearing) to Notice ofDetention and Hearing ................................... 9-33 9-9 Notice of Refusal of Admission .......................................................................... 9-36 9-10 Reconditioning ................................................................................................... 9-38 9-11 Supervisory Charges......................................................................................... 9-43 9-12 Bond Actions...................................................................................................... 9-45 9-13 Import Information Directives ............................................................................. 9-50 9-14 Priority Enforcement Strategy for Problem Importers ........................................ 9-52 Import For Export............................................................................................... 9-60 9-15 9-16 Importations for Trade Shows/Fairs, Exhibits and Special Events ..................... 9-67 9-17 Secured Storage (Temporary Removal Due to Pending Revision) .................... 9-69 9-18 Communication Concerning Assessment of Civil Monetary Penalties by CBP in cases involving Imported Food.......................................................................... 9-70 9-19 Notice of Sampling............................................................................................. 9-71 9-20 Granting and Denying Transportation and Exportation (T&E) Entries................ 9-76 9-21 EXHIBITS.......................................................................................................... 9-79

9-1

Import Procedures

SCOPE AND PURPOSE The procedures outlined in this document cover imported merchandise subject to, but not limited to, the following Acts/Regulations: • • • • • Federal Food, Drug, and Cosmetic Act as amended Fair Packaging and Labeling Act Import Milk Act/Filled Milk Act Federal Caustic Poison Act Radiation Control for Health and Safety Act 9-1

RegulatoryProcedures Manual March 2010

Chapter 9 Import Operations And Actions

____________________________________________________________________________ • • Public Health Service Act, Part F, Subpart 1, Biologic Products Title 21 CFR, especially Part 1, Subpart E - Imports and Exports

Title 19 CFR Customs Duties, especially Part 141, et. seq. dealing with import procedures The purpose of thischapter is to provide an overview of import procedures for articles subject to the laws and regulations enforced by the Food and Drug Administration (FDA). The chapter also includes an overview of laws and regulations enforced by U.S. Customs and Border Protection (CBP), as they relate to importation of articles regulated by FDA. The statements in this chapter represent the Agency's current...