Regulatory Action Details
The company has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Sterile Product Division (SPD) facility in Bengaluru. The report carries a 'Voluntary Action Indicated' (VAI) classification, indicating the inspection found no objectionable conditions and the facility is in acceptable compliance status.
Inspection Timeline
The USFDA inspection was conducted from June 22 to June 30, 2026. The EIR receipt on October 30, 2026 marks the completion of the inspection process.
Management Commentary
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, commented that the VAI classification reflects the company's commitment to maintaining high standards of quality, regulatory compliance and operational excellence. He noted that the SPD facility plays an integral role in the company's sterile manufacturing capabilities for supporting global partners.
Business Context
The SPD facility is part of OneSource's CDMO platform spanning four modalities: drug-device combination, biologics, sterile injectables and soft gelatin capsules. The company operates five manufacturing facilities approved by global regulatory authorities and employs over 1,600 professionals.