USFDA Cites Compliance Concerns for Biocon Unit in Malaysia

The USFDA’s ‘Official Action Indicated’ status may impact product approvals due to manufacturing compliance issues.

Biocon Ltd reported today that the US Food and Drug Administration (FDA) has categorized its group company Biocon Sdn Bhd’s manufacturing facility in Johor, Malaysia as ‘Official Action Indicated’ (OAI) following an inspection, potentially leading to delays in product approvals and supplements. The OAI status indicates that the FDA may withhold approval for pending product applications or supplements associated with this facility until compliance with manufacturing norms is achieved.

In response to a July 2023 Current Good Manufacturing Practice (cGMP) inspection at its insulins manufacturing facility in Johor, Malaysia, Biocon Sdn Bhd, a subsidiary of Biocon Biologics Ltd, received communication from the USFDA. According to a company spokesperson, the USFDA has determined the inspection’s classification as ‘OAI’, implying possible delays or withholding of approvals for pending products due to non-compliance with the manufacturing norms.

Biocon has taken action by submitting a comprehensive Corrective and Preventive Action (CAPA) plan to the USFDA to address observations from the July inspection. The company is committed to completing all necessary actions as per their plan. The spokesperson expressed their intent to collaborate with the FDA to promptly address any remaining concerns. They believe that this issue will not significantly affect the manufacturing and distribution of Biocon’s commercial products in the US market.

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