Corporate News 18-Oct-23
USFDA classifies inspection of Biocon Biologic's Malaysian unit as 'OAI'
Biocon announced that Biocon Sdn Bhd., a step-down subsidiary of Biocon Biologics has received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia. The FDA has determined the inspection classification as “OAI” (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility.
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