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| Wooten Kimbrough Damaso & Dennis, P.A.

Food and Drug Administration (FDA) officials were raked over the coals this week for the administration’s lack of inspections of foreign drug manufacturing plants.  Both Republicans and Democrats expressed their concern that U.S. plants are inspected every two years, while some foreign manufacturers haven’t seen a U.S. inspector for up to 10 years, and some maybe never.  In fact, 81 deaths in the U.S. have been attributed to reactions from contaminated heparin that came from a factory in China that had never been inspected.

FDA Commissioner Andrew C. von Eschenback responded that he agreed more foreign inspections need to be made, but not every two years like the House Energy and Commerce Commission was suggesting.  Rep. John Shimkus, R-Illinois, answered back that he felt the balance of inspections in the U.S. to those of foreign companies did not match the “risk priorities.”


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