Biocon Biologics gets 6 USFDA observations for Malaysia facility
Bangalore: Pharma major Biocon has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with 6 observations at its Malaysian subsidiary Biocon Sdn. Bhd's manufacturing facility.
The USFDA has conducted an on-site pre-approval inspection (PAI) at the company's Malaysian subsidiary Biocon Sdn. Bhd's manufacturing facility for Insulin Aspart between Sep 13 and Sep 24, 2021.
At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities.
"We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the US FDA in the stipulated time. We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US," Biocon Spokesperson said in a statement.
"Biocon Biologics remains committed to global standards of Quality and Compliance," he further added.
Medical Dialogues team had earlier reported that Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., had received the Establishment Inspection Report (EIR) from the USFDA for the pre-approval inspection at two of its biologics manufacturing facilities in Bengaluru.
Read also: Biocon Biologics Gets USFDA EIR For Two Manufacturing Facilities
Biocon Biologics has a platform of 28 biosimilar molecules across diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases.
