Biocon announced that its subsidiary, Biocon Sdn Bhd has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) of its Insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between 10 February and 21 February 2020.
The Inspection has been closed with a 'VAI' (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Febraury 2020.
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