Review of the Accuracy of the Food and Drug Administration's Official Establishment Inventory

EXECUTIVE SUMMARY:

This final report provides the results of our review of the accuracy of the Food and Drug Administration's (FDA) official establishment inventory (OEI)--a computerized data base of establishments under the regulatory purview of FDA.  The FDA is required to inspect, at least once every 2 years, establishments registered with FDA that are engaged in the manufacturer, preparation, propagation, compounding, or processing of drugs and devices.  The FDA inspections identify objectionable conditions and practices and may form the basis for administrative or regulatory action against the establishments such as warning letters, license, suspension, product seizure, injunction, or prosecution.  The FDA's OEI, which listed 135,885 establishments at the time of our review, is not accurate and could be reduced by 21,742 establishments, or 16 percent.  This error rate is higher than the goal FDA set for itself, which is accuracy within 5 percent.  These inaccuracies were due to FDA district offices suspending their quality assurance reviews of their respective portions of the OEI during the transition to an updated management information system.  The FDA agreed with our recommendations for corrective action and provided  a plan for implementation.

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