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Report Shows FDA Weaknesses

Harkin makes recommendations on how to improve FDA inspections.

Compiled by staff

Published: Apr 8, 2010

The Department of Health and Human Services Office of the Inspector General has released a report on the Food and Drug Administration's inspections of domestic food facilities. Among its findings, the report identifies significant weaknesses in FDA's inspections, including the fact FDA inspects less than a quarter of food facilities each year, and that more than half of all food facilities have gone five or more years without an FDA inspection.

Senator Tom Harkin, D-Iowa, who requested the report when he was Chairman of the Senate Ag Committee, says this report shows what has been feared for too long: that the domestic food facilities are not being adequately inspected and FDA needs additional authorities to keep the food on our tables safe. Harkin says this is unacceptable in our modern society.

Harkin recommends the following: (1) FDA increase the frequency of food facility inspections, with particular emphasis on high-risk facilities; (2) provide additional guidance about when it is appropriate to lower OAI classifications; (3) take appropriate actions against facilities with OAI classifications, particularly those that have histories of violations; (4) ensure that violations are corrected for all facilities that receive OAI classifications; (5) consider seeking additional statutory authority that would allow FDA to impose civil penalties through administrative proceedings; and (6) seek statutory authority to allow FDA access to facilities' records during the inspection process.

Harkin hopes this report will spur the Senate past party line bickering to pass the FDA Food Modernization Act of 2009 in order to get the bill reconciled. Michael Taylor, the FDA's deputy commissioner for foods, says legislation is needed that will direct and empower FDA to be proactive, not reactive. Taylor says that the legislation pending in Congress will open up entirely new and much more effective ways to do prevention.

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Tagged: FDA, Food and Drug Administration

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Report Shows FDA Weaknesses

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