Official action indicated for Biocon arm's unit in Malaysia after FDA probe

Biocon Ltd on Wednesday said the US health regulator has classified as 'official action indicated' for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in a regulatory filing. "Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Ltd, has received a communication from the US Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia," a company spokesperson said in the filing. The USFDA 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", the spokesperson added. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product

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