Pre-Approval U.S. FDA Inspection Conducted at Biocon’s Insulins Facilities in Malaysia

  • Posted by: Biocon Biologics


Company Statement

Bengaluru, India, July 8, 2019

“This is to inform you that Biocon Sdn Bhd’s Insulin Glargine Drug Substance, Drug Product and Device assembly facilities in Malaysia underwent a pre-approval inspection by the U.S. FDA between June 24 and July 5, 2019. The inspection across these 3 units concluded with 12 observations issued on the Form 483.

We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously. We do not expect any change to our commercialization plans for Insulin glargine in the U.S. Biocon remains committed to global standards of Quality and Compliance.”

– Company Spokesperson

Author: Biocon Biologics