FDA 483 - Eugia SEZ Private Limited - May 04, 2018

Aurobindo Pharma Limited, an injectable manufacturer in Mahabubnagar District, India, was cited for significant deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate product discrepancies, inadequate cleaning and disinfection procedures in aseptic processing areas, and insufficient employee training for critical operations. These issues indicate a lack of robust quality control and aseptic practices.