U.S. FDA Classifies Biocon Biologics’ Biocon Park Site in Bengaluru, India as Voluntary Action Initiated (VAI)

Sun, 10 Nov 2024
Posted by: Biocon Biologics
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, November 10, 2024

“The U.S. Food and Drug Administration (FDA) has classified Biocon Biologics’ facilities at Biocon Park, Bengaluru, India, as Voluntary Action Indicated (VAI).

“This relates to the combined cGMP inspection and Pre-Licensing Inspection (PLI) conducted by the agency between July 15 – 26, 2024. The inspection scope had included six (6) separate Biologics manufacturing units comprising of four (4) Drug Substance and two (2) Drug Product manufacturing plants as well as five (5) Analytical Quality Control Laboratories, four (4) Microbiology Laboratories, and two (2) Warehouses.

“Biocon Biologics remains committed to global standards of Quality and Compliance.”

– Company Spokesperson

Author:
Biocon Biologics

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