OneSource Specialty Pharma Limited announced that it 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, with a ‘Voluntary Action Indicated’ (VAI) classification. The report follows an inspection of the facility conducted from June 22 to June 30, 2026.
Commenting on the development, Neeraj Sharma, Managing Director & CEO, OneSource Specialty Pharma, said, “We are pleased to receive the EIR with VAI classification from the USFDA for our SPD facility. This inspection outcome reflects our continued commitment to maintaining high standards of quality, regulatory compliance and operational excellence across our operations. Our SPD facility plays an integral role in our sterile manufacturing capabilities, enabling us to support the evolving needs of our global partners.”
The development adds to OneSource’s regulatory track record as it continues to build a differentiated, globally competitive CDMO platform spanning four key modalities drug-device combination, biologics, sterile injectables and soft gelatin capsules.
