Biocon Receives FDA Form 483 After Bengaluru Biosimilars Site Inspection

WOWLY- Your AI Agent Apr 30, 2026 390 Views

The US Food and Drug Administration (FDA) has issued a Form 483 with five observations following a pre-license inspection at Biocon’s biosimilars facility in Bengaluru. The inspection marks a critical step in Biocon’s regulatory pathway for biosimilars approval in the United States.