FDA 483 - EUGIA Pharma Specialities Limited - May 03, 2024

EUGIA Pharma Specialities Limited, a sterile drug manufacturing site in Bhiwadi, India, was cited for significant deficiencies in its aseptic processing, quality control, and contamination prevention systems. The inspection revealed failures in following procedures to prevent microbiological contamination, inadequate validation of aseptic processes, and insufficient investigation into discrepancies and out-of-specification results. Additionally, the firm lacked proper controls to prevent cross-contamination between different pharmaceutical products and exhibited shortcomings in environmental monitoring and cleaning procedures.