FDA Import Operations – Embassy Training Seminar

Objective of Operations

  • Operate within the context of Efficient Risk Management for public health and safety
  • Ensure imported regulated products that pose or appear to pose a threat or risk to public health and safety are not allowed entry, or are otherwise mitigated
  • Facilitate expedited movement of imported goods of little or lesser risk to public health and safety

Currently, how is Entry Information Received?

  • Most entries are made electronically via interface with Bureau of Customs and Border Protection ACS system
  • Most entries are entered into the system by Customs House Brokers (also called Filers by FDA)
  • Entry data from Customs goes to FDA’s electronic system , OASIS

Entry Information continued

  • FDA’s electronic OASIS system is the primary mechanism used by the field inspectors for entry review, work flow, and generation of notices to the importers related to specific entries
  • Product Center databases also used for determining admissibility
  • OASIS system is primary tool for FDA HQ to implement selectivity criteria nationwide including Import Alerts
  • OASIS and ACS selectivity criteria is coordinated at the HQ level of both CBP and FDA

Challenge of Numbers FY2003

  • 9.4 million lines of entry of all FDA regulated products
  • Products imported from 200+ (two hundred)countries
  • Products made by 200,000+ declared foreign manufacturers/processors
  • Products enter through approx. 300 Customs ports
  • Approximately 1/3 of all exports to the U.S. are FDA regulated products
  • Project approx. 11 million lines in FY 2004

Current Day to Day Import Operations

  • Most industry/FDA interaction is at the FDA field district office level covering certain port areas
  • If FDA entry reviewer finds product in an entry «appears» to violate provisions of the FD & C Act, local office issues appropriate notice of apparent violation
  • Importer, owner, or consignee has opportunity to provide evidence to overcome the «appearance» of violation.
  • If appearance of violation is not overcome, entry is refused and Customs advised.
  • Refused articles are destroyed or exported under Customs rules

Current Day to Day Import HQ Operations

  • Develop and implement import enforcement procedures and policies based on risk
  • Implement Import Alerts and evaluate petitions for removal from import alerts
  • Manage selectivity criteria in OASIS
  • Coordinate import activities among various Agency components including field and headquarter units and other federal agencies (CBP, USDA, etc)
  • Provide HelpDesk support for OASIS
  • Identify need for and conduct training for FDA personnel


  • Commissioner’s Strategic Action Plan
  • Implementing provisions of the «Public Health Security and Bioterrorism Preparedness and Response Act of 2002»
  • IT improvements for management of information related to chain of supply
  • Revision/Update of Regulatory Procedures Manual Chapter 9

Mutual Objective

  • Ensure FDA regulated products in international trade are safe and secure.
  • Ensure business practices of the foreign manufacturer to the U.S retailer (product life-cycle) are in alignment with goal of delivering products that are safe and secure
  • Collaborate/partner to establish workable methods to mitigate potential risks of products prior to arrival at U.S. ports so trade is efficient and safe.


Carl Nielsen
Director, Division of Import Operations and Policy