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

Source: https://www.globalkeysolutions.net/records/483/tentamus-india-private-limited/107a5962-221b-47a2-9886-ddb8f1849cbc

> FDA 483 for TENTAMUS INDIA PRIVATE LIMITED on August 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TENTAMUS INDIA PRIVATE LIMITED
- Inspection Date: 2025-08-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/tentamus-india-private-limited/98546c5a-01a9-4157-9fc2-9254a69641af

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1