On closure of USFDA inspection
Alkem Laboratories announced that the USFDA 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 USFDA.The USFDA had inspected the Baddi manufacturing facility from 2 to 10 March 2017 and had issued Form 483 with 3 observations. Post this, the Company has submitted a detailed corrective and preventive action plan to the regulator within stipulated timelines.
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