FDA 483 - Eugia Pharma Specialities Limited - December 14, 2018

An FDA inspection of Aurobindo Pharma Limited - Unit IV in Hyderabad, India, revealed significant deficiencies in aseptic processing. The firm failed to establish and follow adequate procedures to prevent microbiological contamination of sterile drug products, with issues noted in environmental monitoring, smoke studies, and media fill simulations. Additionally, protective apparel was not consistently worn to protect drug products from contamination.