FDA 483 - Eugia Steriles Private Limited - June 19, 2026

Eugia Steriles Private Limited in Anakapalli, India, a sterile drug product manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight critical issues in aseptic processing procedures, validation of aseptic processes, quality control unit responsibilities, and the adequacy of investigations into discrepancies. These findings indicate a high risk of microbiological contamination and a lack of robust quality systems.