Alkem Laboratories announced the USFDA has issued an Establishment Inspection Report (EIR) for the Company's manufacturing facility
located at Amaliya, Daman, India which was inspected from 19 March, 2018 to 27 March, 2018.
In response to the Form 483 issued by the US FDA containing thirteen observations, the Company had submitted a detailed corrective and preventive action (CAP A) plan to the regulator within the stipulated timeline. The inspection has now been closed by the US FDA.
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