USFDA18 Dec 2025, 05:51 pm
Biocon Ltd Receives VAI Status from US FDA for Biocon Generics Inc Facility in Cranbury, New Jersey
AI Summary
Biocon Ltd has announced that it has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA) for its Biocon Generics Inc facility in Cranbury, New Jersey. The inspection by the US FDA was conducted between the 6th to 10th of October, 2025.
Key Highlights
- Biocon Ltd has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA)
- The inspection was conducted at the Biocon Generics Inc facility in Cranbury, New Jersey
- The inspection was conducted between the 6th to 10th of October, 2025
- This is a significant milestone for Biocon Ltd in its US operations
- The VAI status indicates that the US FDA has found no major issues during the inspection