FDA 483 - Eugia SEZ Private Limited - March 01, 2019

Aurobindo Pharma Limited, a manufacturer of sterile drug products in Mahabubnagar District, India, received 11 observations during an FDA inspection. The observations highlight significant deficiencies across quality control, manufacturing process validation, complaint investigations, employee training, environmental monitoring in aseptic areas, and laboratory controls. These issues indicate a lack of robust systems to ensure the quality, sterility, and purity of their drug products.