FDA 483 - Eugia Steriles Private Limited - April 05, 2024

This FDA Form 483 was issued to Eugia Steriles Private Limited, a manufacturer located at Plot Nos. 1, 2, 2a & 2b, Industrial Park, Parawada Phase III, Anakapalli, Andhra Pradesh, 531021 India. The inspection was conducted from March 28, 2024, to April 5, 2024. Yugandhar Puvvala, CEO and Executive Director, was the recipient of the report.

The inspection revealed three main observations:

**Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.** * Cleaning procedures for the RABS (Restricted Access Barrier System) were inadequate, lacking instructions for proper cleaning order and failing to verify sporicidal agent effectiveness on all surfaces. * Line clearance procedures were not followed, with an employee failing to document a non-functional spray bottle and out-of-calibration equipment, and not verifying hold times for sterilized equipment. * Biological indicator incubation times for sterilization cycles did not adhere to manufacturer recommendations, and necessary precautions for extended incubation were not provided. * Production employees climbed inside sterilization chambers without shoe covers for manual cleaning. * Residue was observed on vials post-sterilization, indicating ineffective cleaning. * Corrective actions for environmental monitoring excursions in a Grade C area were not effective