FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - August 14, 2025

An FDA inspection of Tentamus India Private Limited in Hyderabad revealed significant data integrity issues and a lack of adequate quality control oversight. Observations included the destruction and backdating of GMP documents, use of personal diaries for critical data, and failure to properly investigate discrepancies and maintain laboratory controls. These findings indicate a systemic breakdown in the firm's quality unit responsibilities and documentation practices.