ONESOURCE SPECIALTY PHARMA LIMITED – FDA 483, Mar 28, 2025
ONESOURCE SPECIALTY PHARMA LIMITED, a sterile drug manufacturer in Bengaluru, India, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed inadequate validation of aseptic processes, including media fills and air flow studies, and a failure to establish robust process control procedures with statistical sampling. Additionally, the firm's intervention procedures for vial filling were incomplete, and its environmental monitoring program did not adequately account for dynamic manufacturing conditions.
ID · 9bd2bb77-3188-4c4f-bf85-189380be4b13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.