FDA 483 - Syngene International Ltd. - February 20, 2025

An FDA inspection conducted at Syngene International Ltd. in Bengaluru, India, from February 10 to February 20, 2025, revealed several significant deficiencies concerning Good Manufacturing Practices (GMP). The facility manufactures APIs, drug substances, and finished drug products.

Key observations included a failure to adequately verify critical consumable components, such as those impacting product safety and purity, by not confirming data on Certificates of Analysis. The environmental monitoring program was found to be insufficient, with area classifications based on static conditions rather than dynamic operations, and a lack of comprehensive personnel monitoring for all staff in classified production areas.

Investigations into nonconformances, including environmental monitoring excursions and missing data, were deemed inadequate, with concerns raised about the integrity of documented evidence. Furthermore, controlled documents were not secure, demonstrating that batch records could be modified post-review, undermining quality control systems. Finally, facility design was cited as deficient, with exposed ceiling materials in classified areas creating hard-to-clean surfaces conducive to contamination.

These observations indicate a need for Syngene International to implement robust corrective and preventive actions to ensure the reliability of components, enhance environmental and personnel monitoring, strengthen nonconformance investigations, secure controlled documentation, and improve facility design to meet regulatory expectations for pharmaceutical manufacturing.