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FDA scaling back API facility inspections in US; Socma asks FDA to ensure frequency of inspections does not exceed three years

4:28 AM MDT | May 30, 2014 | Deepti Ramesh

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of Socma, issued a letter on 27 May to the US Food and Drug Administration (FDA) asking that the agency ensure the frequency of inspections for any domestic active pharmaceutical ingredient (API) manufacturer remains consistent. It was recently disclosed that the FDA would be scaling back by nearly 40%, the number of domestic API inspections it plans to conduct in fiscal years 2014 and 2015, in order to increase the number of foreign inspections. BPTF, which is an association for manufacturers of APIs...

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