FDA 483 - Eugia Pharma Specialities Limited - January 27, 2026

The FDA inspected Eugia Pharma Specialties Limited, a sterile drug product manufacturer in Sangareddy, Telangana, India, from January 27 to February 6, 2026. The inspection revealed significant deviations from Good Manufacturing Practices (GMP) related to sterile drug product manufacturing. Key violations include inadequate procedures to prevent microbiological contamination, with observations of poor aseptic techniques during critical operations, insufficient glove monitoring, and environmental monitoring procedures not being followed. The company"s validation of aseptic processes was found deficient, with unvalidated recovery times after environmental degradation and flawed airflow visualization studies that did not represent actual manufacturing conditions. The quality control unit failed to thoroughly review discrepancies and batch failures. This included insufficient investigations into media fill turbidities, maintenance activities impacting product sterility without proper deviation management or investigation, and inadequate investigation of consumer complaints concerning drug efficacy. Environmental monitoring systems were also deficient, as personnel performing Grade A interventions were not monitored to appropriate standards, interventions were not documented, and non-viable particle count (NVPC) excursions were not properly addressed, with manufacturing continuing despite out-of-specification results. To address these observations, Eugia Pharma Specialties Limited must implement comprehensive corrective and preventive actions. This includes revising and strictly following aseptic procedures, validating all critical processes, enhancing environmental and personnel monitoring, improving visual oversight of aseptic manipulations, and ensuring thorough investigation of all deviations and consumer complaints to ensure the sterility and quality of their drug products.