FDA 483 - Eugia Pharma Specialities Limited - February 06, 2026

Eugia Pharma Specialities Limited received a Form 483 citing significant deficiencies in aseptic processing, quality control, and laboratory practices. Observations included poor aseptic techniques, inadequate validation of sterile processes, insufficient monitoring of critical interventions, and failures in investigating discrepancies and consumer complaints. The firm also lacked proper training for visual inspectors and had issues with environmental monitoring and laboratory record review.