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| Exchange Received Time 12/04/2017 11:40:24 Exchange Disseminated Time 12/04/2017 11:40:30 Time Taken 00:00:06 | | Sub: Intimation U/R 30 of the SEBI(LODR) Regulations- Reg. This is to inform you that the US FDA has issued an Establishment Inspection Report (EIR) for the Company's Active Pharmaceutical Ingredient (API) manufacturing facilities located at Raichur, Karnataka, India which was inspected between 12th and 16th December 2016. The inspection has now been closed by the US FDA. The Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection. The US FDA has reviewed the CAPA and has found them acceptable. |
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