FDA 483 - Raptim Research Pvt. Ltd. - July 25, 2025

An FDA inspection of Raptim Research Private Limited, a Contract Research Organization in Navi Mumbai, India, revealed significant deficiencies across multiple areas. The firm failed to adhere to its own standard operating procedures, maintained inadequate documentation for study reconstruction, and demonstrated inconsistent practices. Additionally, issues with raw data management and computer system backups were identified, indicating systemic control failures.