FDA Import Automation

Serious Management and Systems Development Problems Persist Gao ID: AIMD-95-188 September 28, 1995

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.

GAO found that: (1) although some improvements have been made to import operations, FDA has not completed OASIS after 8 years and about $14 million in system development costs, mainly due to inadequate management oversight; (2) in 1994, FDA determined that OASIS was at a high risk for failure and it should suspend development until it completed a comprehensive system review; (3) FDA has taken an inadequate approach in developing OASIS, resulting in the potential for unsafe products entering the country; (4) FDA completed the comprehensive review of OASIS in June 1995 and determined that OASIS was not ready for national implementation and recommended an immediate reengineering effort; and (5) FDA success in improving OASIS depends on better planning and top management involvement in system design, development, and deployment.


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