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Audit (A-01-07-01503)

08-12-2009
Review of the Food and Drug Administration's Monitoring of Pet Food Recalls

Executive Summary

We found that FDA does not have statutory authority to require manufacturers or importers to initiate pet food recalls or to assess penalties for recall violations. Furthermore, FDA issued its regulations as nonbinding recall guidance for firms. Several bills proposed in the 110th session of Congress would have provided FDA with authority to mandate recalls and to dictate and enforce the terms of a recall.

FDA has developed procedures for monitoring recalls and assessing a firm's recall effectiveness. However, FDA did not always follow its procedures in overseeing three of the five recalls that we reviewed. Furthermore, FDA's procedures were not always adequate for monitoring large recalls. FDA's lack of authority, coupled with its sometimes lax adherence to its recall guidance and internal procedures and the inadequacy of some of those procedures, limited FDA's ability to ensure that contaminated pet food was promptly removed from retailers' shelves.

Our report contains detailed recommendations for strengthening FDA's recall authority and improving its effectiveness in monitoring food recalls. FDA agreed or agreed in principle with all of our recommendations.

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