FDA Grants VAI Status to Biocon’s Biologics Facilities, Reflecting Compliance
Biocon’s Bengaluru site earns FDA's VAI status after inspection, signaling compliance with minor observations.
The U.S. FDA has classified Biocon Biologics' facilities at Biocon Park in Bengaluru, India, as "Voluntary Action Indicated" (VAI) after conducting a thorough cGMP and Pre-Licensing Inspection (PLI) in July 2024. This inspection covered multiple biologics manufacturing units, including four drug substance and two drug product plants, as well as multiple quality control and microbiology laboratories and warehouses.
The VAI status indicates that, while minor observations were noted, they do not require further regulatory action by the FDA. Biocon Biologics reaffirmed its dedication to meeting global quality and compliance standards across its operations.
My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.
Altro da Pharma News
Tutti gli articoli →
Curia New York riceve una lettera di richiamo (Warning Letter) dalla FDA per migliaia di iniezioni cromatografiche non documentate
Ab Science rivede i tempi dei trial dopo tre ispezioni GCP
Discussion