January 22, 2018 / 8:57 AM / 3 months ago

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

Reuters Staff

1 Min Read

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 Source text - bit.ly/2F0R0U9 Further company coverage:

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