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BRIEF-Alkem Labs says US FDA issues EIR for Baddi manufacturing facility
May 23, 2017 / 7:36 AM / 4 months ago

BRIEF-Alkem Labs says US FDA issues EIR for Baddi manufacturing facility

May 23 (Reuters) - Alkem Laboratories Ltd

* Says US FDA has issued an establishment inspection report for its Baddi manufacturing facility

* Says inspection has now been closed by the USFDA Source text: [Alkem Laboratories Limited has informed the Exchange regarding a press release dated May 23, 2017, titled “Closure of US FDA Inspection at Alkem s Baddi Facility”. 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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