Following USFDA inspection and receipt of one Form 483 observation
Alkem Laboratories announced that the USFDA had conducted an inspection at the Company's manufacturing facility located at St. Louis, USA from 12 March, 2018 to 16 March, 2018. In response to the one Form 483 observation issued by the US FDA, the Company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.Powered by Capital Market - Live News
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