Apitoria Pharma Private Limited – FDA 483, Oct 21, 2019

Aurobindo Pharma Ltd., Unit V, a sterile and non-sterile bulk drug manufacturer, was inspected and cited for four observations. Deficiencies included inadequate laboratory controls for out-of-specification (OOS) results, equipment design issues impacting aseptic operations, insufficient environmental monitoring in aseptic areas, and incomplete process validation for sealing and manufacturing parameters. These issues indicate a lack of robust controls to ensure drug substance quality and sterility.