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Shilpa Medicare receives EIR report for facility in Jadcherla in Telangana

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From USFDA

Shilpa Medicare announced that the US FDA has issued an Establishment Inspection Report (EIR) for the Company's generic pharmaceutical manufacturing facility at Jadcherla in Telangana, India which was inspected between 24 and 28 July 2017. 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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First Published: Oct 07 2017 | 4:16 PM IST

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