Review of the Food and Drug Administration's Processing of 17 Error and Accident Reports Involving Blood

EXECUTIVE SUMMARY:

This review was made to determine if the Food and Drug Administration (FDA) took all required actions regarding 17 error and accident reports identified as requiring further evaluation for a blood recall classification. Classification and publication of a blood recall generally take place long after the error or accident occurs. Our final report discloses that FDA had not processed 5 of the 17 reports in accordance with established procedures. Although errors in processing the 5 reports caused delays in classifying the blood recalls, the FDA does not believe the public was placed at additional risk. We recommended that FDA improve its tracking system to ensure that all error and accident reports warranting further evaluation for blood recall classification are tracked until final resolution. We also recommended that FDA complete the recall classification and publication of the 5 error and accident reports identified in our review. The FDA concurred with our recommendations and has taken corrective action.