Bharat Parenterals Subsidiary Receives 5 FDA VAI Observations

Bharat Parenterals subsidiary Innoxel Lifesciences received 5 observations under Voluntary Action Indicated classification from surprise US FDA inspection.
Inspection occurred April 13-17 and 20, 2026 at Vadodara sterile injectables facility serving US and EU markets.
Company will respond within prescribed timelines; final Establishment Inspection Report is still awaited.
Facility recently received EU GMP certificate with zero critical/major observations in November 2025 inspection.