FDA 483 - Samanta Organics Pvt. Ltd. - January 17, 2025

Samanta Organics Pvt. Ltd., an API manufacturer in Boisar, Maharashtra, was cited for significant data integrity and quality system deficiencies during an FDA inspection. Observations included a QA manager altering and backdating incident reports, inadequate electronic data security, and an insufficient environmental monitoring program lacking acceptance criteria for critical areas. These issues indicate a serious breakdown in quality control and data management practices.