Update on Company Statement on US-FDA Inspection at Biocon Malaysia

  • Posted by: Biocon Biologics

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.

Author: Biocon Biologics