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USFDA Pulls Up Smruthi Organics Ltd For Norms Violation In Unit - Business Standard


Monday, 21 Oct 2013 05:40am EDT 

Business Standard reported that Smruthi Organics Ltd has received a notification from the USFDA highlighting violations of manufacturing norms at its Solapur plant. In a filing to the BSE, the Company said European Directorate for Quality of Medicines (EDQM) and the US Food and Drug Administration (USFDA) have inspected its active pharmaceutical ingredients site from October 14-18, 2013. USFDA has issued their observations in form 483. EDQM is yet to submit its final inspections report, Smruthi Organics Ltd added. 

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