Steriscience Specialties Private Limited – FDA 483, Jun 30, 2026

OneSource Specialty Pharma Limited, a sterile drug manufacturer in Bengaluru, India, received a Form 483 for significant deficiencies in its procedures to prevent microbiological contamination during the production of sterile drug products. The inspection revealed multiple instances where established procedures were not followed or were inadequate, posing a high risk to product sterility. These issues included failures in covering bulk drug tanks, inadequate gowning requirements, and insufficient disinfection practices in critical manufacturing areas.