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

EUGIA Pharma Specialities Limited, a sterile pharmaceutical manufacturer in Medchal-Malkajgiri District, India, was inspected by the FDA from February 16-27, 2026. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental monitoring, personnel practices, and a lack of aseptic process validation. Additionally, issues were noted in laboratory controls regarding visual inspection qualification and incomplete investigations into consumer complaints of glass particulates in sterile injectable products.