13th March, 2018
"Biocon had issued a statement to the stock exchanges on Feb 21, 2018, that the US-FDA completed a pre-approval inspection of its manufacturing facility in Malaysia and issued a Form 483 with 6 observations. As per the normal process, the Company has already submitted the Corrective and Preventive Action Plan (CAPA) to address these observations to the regulator" - Biocon Spokesperson.
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