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| Exchange Received Time 23/05/2017 13:00:33 Exchange Disseminated Time 23/05/2017 13:00:43 Time Taken 00:00:10 | | In furtherance to the intimation captioned 'Update on US FDA Inspection at Alkem's Baddi Facility' dated 10th March, 2017, this is to inform you that the US FDA has issued an Establishment Inspection Report (EIR) for its Baddi manufacturing facility which was inspected in March 2017. The inspection has now been closed by the US FDA. In response to the Form 483 issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. A copy of Press Release is enclosed herewith for your information. Kindly take the same on record. |
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