cGMP inspection and PLI were conducted by the USFDA between July 15 – 26, 2024

United States Food and Drug Administration (USFDA) has classified Biocon Biologics’ Biocon Park Site in Bengaluru as Voluntary Action Indicated (VAI).

According to the company’s statement, this is related to the combined current good manufacturing practices (cGMP) inspection and Pre-Licensing Inspection (PLI) conducted by the USFDA between July 15 – 26, 2024.

A company spokesperson said that the inspection scope had included six (6) separate Biologics manufacturing units consisting 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.