# FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - July 15, 2016

Source: https://www.globalkeysolutions.net/records/483/tentamus-india-private-limited/2b7ebd05-6ed1-499a-988e-3b0f0db3d08e

> FDA 483 for TENTAMUS INDIA PRIVATE LIMITED on July 15, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TENTAMUS INDIA PRIVATE LIMITED
- Inspection Date: 2016-07-15
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Megan Labs Private Limited, a control testing laboratory in Hyderabad, India, was inspected by the FDA from July 13-15, 2016. The inspection revealed significant deficiencies in laboratory controls, including inadequate calibration procedures for testing equipment and a lack of scientific justification and defined protocols for out-of-specification (OOS) investigations and retesting. These issues indicate a failure to ensure the quality and purity of drug components and products.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/andrew-j-idzior/5b639c02-d062-4a5a-aa4a-8362ddfba2b6)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321