Outcome of the U.S. FDA Inspection at Innoxel Lifesciences Private Limited subsidiary Company of Bharat Parenterals Limited

The U.S. FDA conducted a surprise inspection at Innoxel Lifesciences' sterile injectables manufacturing facility in Vadodara from April 13-20, 2026. Five observations were issued under a Voluntary Action Indicated (VAI) classification, which means the FDA found some procedural issues but is not recommending immediate regulatory action. The company will respond within prescribed timelines and awaits the final Establishment Inspection Report. The facility is a key supplier of sterile injectable formulations to regulated markets including the US and EU. Notably, the same facility received zero critical and zero major observations during an EU GMP inspection in November 2025.