FDA 483 - Steril-Gene Life Sciences Private Ltd - March 03, 2025

Steril-Gene Life Sciences Private Ltd, a human drug manufacturer in Puducherry, India, was cited for significant deficiencies across three observations. The inspection revealed inadequate laboratory controls for sterility testing, including method suitability and control processes, which could lead to false-negative results. Additionally, the firm lacked established and followed written procedures for in-process visual inspections, particularly concerning personnel training and qualification for detecting foreign material in drug products. Finally, procedures to prevent microbiological contamination of sterile drug products were not followed, with issues in aseptic personnel qualification and environmental monitoring.