Summary: The Food and Drug Administration (FDA) oversees imports of food, drugs, cosmetics, medical devices, and other products to ensure that the public is protected from goods of questionable quality or that make misleading claims. In 1987, FDA began developing an automated system to improve its import entry clearance process, which required extensive paperwork. Despite an investment of eight years and $13.8 million to automate its process for inspecting imported goods, the new system contains major deficiencies. This is due mainly to inadequate top management oversight and a management team that lacked expertise and skills in system development. FDA has implemented a portion of the system--the Operational and Administrative System for Import Support (OASIS)--to enhance its ability to regulate imports and to relieve importers and FDA personnel of some of the paperwork burdens associated with import processing. In developing OASIS, FDA did not follow generally accepted systems development practices for validating software; conducting user acceptance testing; developing a security plan to safeguard its computer facilities, equipment, and data; and conducting a cost-benefit analysis. The resulting shortcomings mean that OASIS may not perform as needed and that unsafe products could enter the country.
