Evaluation of Selected Aspects of FDA's Food Manufacturing Sanitation Inspection Efforts

Highlights

In response to a congressional request, GAO developed information on the status of sanitation conditions in the food manufacturing industry and the Food and Drug Administration's (FDA) management of its inspection activities. In addition, GAO reviewed the ability of FDA to enforce regulations which ensure that foods are manufactured under sanitary conditions.

Recommendations

Recommendations for Executive Action

Agency Affected	Recommendation	Status
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner of FDA to continue to review the current food manufacturing establishment inventory and remove those establishments with little or no interstate shipment of foods unless FDA finds a compelling need for continued inspection of such establishments.	Closed – Implemented FDA reviewed the 85 etablishments in GAO's nationwide sample to justify the basis for continued inspection. It stated that 69 establishments must be included in its inspection inventory. FDA did not contact state inspection agencies to determine their inspection frequency and responsibilities for the 69 establishments. FDA believes an entire inventory review is not needed.
Department of Health and Human Services	The Secretary of Health and Human Services should direct the Commissioner of FDA to consider the sufficiency of the current level and allocation of inspection resources devoted to the food sanitation and quality control programs and make appropriate adjustments recognizing the reduced inventory and extent of inspection coverage needed to adequately monitor food manufacturing establishments.	Closed – Not Implemented FDA stated that, based on an analysis of the 85 establishments, it planned no steps to delete establishments with less than 10 percent interstate sales. FDA will review its inventory adding or removing establishments and adjusting resources as necessary. GAO believes that resources need to be adjusted for FDA-inspected establishments with little or no interstate commerce.

Full Report

(23 pages)

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