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Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process

Our ongoing audit of FDA's food recall program found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation's food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.

We suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.

Copies can also be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.

Download the complete report.

Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201