Alkem Laboratories announced that its manufacturing facility located at St. Louis, USA has received an Establishment Inspection Report (EIR) issue by the USFDA following inspection from 12 March, 2018 to 16 March, 2018.
In response to the Form 483 issued by the US FDA containing one observation, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.
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