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India

India's Shilpa Medicare Says U.S. FDA Issues 3 483 Observations To Co's Karnataka Units


Monday, 22 Jan 2018 

Jan 22 (Reuters) - Shilpa Medicare Ltd ::US FDA COMPLETED INSPECTION OF CO'S API FACILITIES UNIT-I AND UNIT-II LOCATED AT RAICHUR, KARNATAKA.SAYS INSPECTION CLOSED BY US FDA WITH THREE 483 OBSERVATIONS.IN PROCESS OF SUBMISSION OF CAPA PLAN TO REGULATOR WITHIN STIPULATED TIMELINES IN RESPONSE TO FORM 483 ISSUED. 

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