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 applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.

The spokesperson said the company has submitted a comprehensive corrective and Preventive Action (CAPA) plan to the USFDA in response to observations from the July inspection and believe it is on track to complete all actions as committed.

“The company will continue to engage with the agency to understand any outstanding concerns and work closely to address them expeditiously. We do not believe that this will have a material impact on the manufacturing and distribution of the company’s commercial products for the US market,” the spokesperson said.