Review of the Food and Drug Administration's Inspection Process of Plasma Fractionators

EXECUTIVE SUMMARY:

This final audit report points out the results of our review made to determine if the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) followed its internal procedures regarding 17 error and accident reports it had identified as requiring further evaluation for a blood recall classification. Our review disclosed that FDA processed 12 of the 17 error and accident reports in accordance with established procedures. Five of the 17 reports were not processed in accordance with established procedures. Although errors in processing the five error and accident reports caused delays in classifying the blood recalls and publishing them in the FDA Enforcement Report , FDA does not believe the public was placed at additional risk. Classification and publication of a blood recall generally take place long after the error or accident occurs.

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 recommend that FDA complete the recall classification and publication of the five error and accident reports identified in the report as not being processed in accordance with established procedures. The FDA agreed with our recommendations.