FDA 483 - EUGIA Pharma Specialities Limited - November 14, 2025

An FDA inspection of EUGIA Pharma Specialities Limited in Bhiwadi, India, revealed critical deficiencies in aseptic processing and quality control for sterile drug products. The firm failed to adequately monitor critical interventions, follow aseptic procedures, validate aseptic processes, and maintain an effective environmental monitoring program. These findings indicate a significant risk to the sterility assurance of their manufactured products.