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Audit (A-01-09-01500)

Review of the Food and Drug Administration's Monitoring of Imported Food Recalls

Executive Summary

Our review found that FDA's guidance for developing and implementing food recalls was not adequate to ensure the safety of the Nation's food supply because it was not enforceable. In addition, FDA did not always follow its own procedures for ensuring that the recall process operated efficiently and effectively. FDA has established regulations as nonbinding guidance that FDA and the recalling firm should consider in planning and implementing a recall. From July 1, 2007, through June 30, 2008, FDA oversaw 40 Class I recalls of imported food products contaminated with pathogens and other harmful substances that can cause serious illnesses. We reviewed FDA's monitoring of 17 of the 40 recalls.

Our review of FDA's records relating to the 17 recalls found the following problems: firms did not promptly initiate recalls, firms did not submit recall strategies or strategies did not contain complete information, firms did not issue accurate and complete recall communications to their consignees, and firms did not submit timely and complete recall status reports. In addition, FDA did not always (1) conduct firm inspections or obtain complete information on the contaminated products, (2) conduct timely or complete audit checks of consignees, (3) review recall strategies and promptly issue notification letters to firms conveying the review results and other essential instructions, or (4) witness the disposal of the products or obtain the required documentation showing that the products had been properly disposed of.

We recommended that FDA (1) consider the results of this review in implementing the FDA Food Safety Modernization Act and (2) comply with its procedures

for monitoring recalls. FDA agreed with our recommendations and described actions it has taken to improve how recalls are conducted and monitored.

Complete Report

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