FDA 483 - Eugia Steriles Private Limited - February 18, 2025

During an inspection from February 10-18, 2025, the FDA issued a Form 483 to Eugia Steriles Private Limited, a sterile drug manufacturer in Anakapalli, India, detailing significant observations related to Good Manufacturing Practices (GMP). Key issues included inadequate investigation records, with the firm failing to implement corrective actions for critical process nonconformances like a failed media fill and unaddressed atypical analytical results. Procedures to prevent microbiological contamination were found deficient, as operators did not consistently sanitize filling line areas, no sanitization procedure existed for critical RABS components, and environmental monitoring was incomplete. The inspection also revealed a failure to follow established sampling procedures for sterility and bacterial endotoxin testing, casting doubt on sample representativeness. Furthermore, the firm lacked validated production controls, specifically an unvalidated stoppering process without defined parameters or an audit trail, and employees performing visual inspection of certain drug products were not adequately qualified or trained. These observations highlight significant deviations from regulatory expectations, requiring comprehensive corrective actions from Eugia Steriles Private Limited to ensure drug product quality and sterility.