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Unannounced Inspections in India And China to be Resumed Soon: USFDA

Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in foreign countries, especially in India and China.

Unbeknownst to many consumers 80 per cent of active pharmaceutical ingredients are produced abroad, the majority in China and India; however, the FDA only inspected one in five registered human drug manufacturing facilities abroad last year, he said

Grassley raised the issue in a letter, dated August 7, to Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless.

Also in February, FDA plans to resume prioritized foreign inspections, will be seeing more type of hybrid assessments going forward.

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