Mumbai, June 10 -- The facility received a "Voluntary Action Indicated" (VAI) classification from the USFDA, following an inspection conducted between March 20 and March 28, 2025. During the inspection, the agency issued a Form 483 with four observations. However, after reviewing the company's comprehensive response and commitments, the agency has officially closed the inspection.
Neeraj Sharma, managing director & CEO, said "The successful closure of our latest USFDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in Drug Device Combinations (DDC), biologics drug substa...