FDA 483 - EUGIA Pharma Specialities Limited - February 27, 2026

EUGIA Pharma Specialities Limited, a sterile pharmaceutical manufacturer in Medchal-Malkajgiri District, India, was cited for significant deficiencies in its aseptic processing, laboratory controls, and complaint investigations. The inspection revealed failures to prevent microbiological contamination, inadequate validation of aseptic processes, and insufficient procedures for visual inspection qualification. Furthermore, the firm failed to thoroughly investigate numerous consumer complaints regarding glass particulates and container closure integrity issues in distributed sterile drug products.