The US FDA classified Biocon Ltd. as ‘official action indicated’ after inspecting its Johor, Malaysia manufacturing plant. This could delay or withhold product approvals or supplements. Biocon sent a corrective and preventive action plan
to the FDA.

After an examination, Biocon Ltd. claimed the US health authorities designated its Johor manufacturing plant as ‘official action indicated’ on Wednesday. Biocon Ltd. stated in a regulatory filing that the facility’s OAI status may delay or withhold product approvals or supplements.

“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 spokeswoman for the firm stated.

FDA “classified inspection as ‘OAI’ (Official Action Indicated). The spokesman said that OAI status may delay or withhold facility product approvals or supplements.

According to the USFDA, OAI means the regulator may withhold clearance of any pending product applications or supplements from such facility until it resolves manufacturing norm violations.

In response to the July inspection, the spokesman stated the company has submitted a comprehensive corrective and preventive action (CAPA) plan to the USFDA and is on pace to complete all steps.

“The organization will cooperate with the agency to understand and resolve any issues quickly. This should not affect the company’s US commercial product manufacturing and distribution, the representative said.

Conclusion

The FDA designated Biocon Ltd, a subsidiary of Biocon Biologics Ltd, as ‘official action indicated’ after a July 2023 cGMP inspection at its insulin production facility in Johor, Malaysia. The FDA’s ‘OAI’ inspection categorization may delay or withhold product approvals or supplements from the facility. The FDA’s OAI status means it may defer approval of facility product applications or supplements until manufacturing norm infractions are resolved. Biocon Ltd. has submitted a thorough CAPA plan to the FDA and believes it will complete all measures.

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