Biocon Receives CRL for Unresolved Manufacturing Issues

India-based Biocon Biologics has received a Complete Response Letter (CRL) from the FDA calling for more data on its biologics license application for a form of regular insulin (insulin-R) and evidence the company has resolved manufacturing problems uncovered in a preapproval inspection.

The CRL refers to an August 2022 preapproval inspection that required Biocon to establish a corrective and preventive action (CAPA) plan to address the problems.

“The CRL cites … an expectation of a satisfactory implementation of a CAPA plan pertaining to the preapproval inspection,” the company said. “We are in the process of comprehensively addressing the CRL.”

The company had previously received a Form 483 for numerous documentation problems observed during a 2020 inspection.