# FDA 483 - TENTAMUS INDIA PRIVATE LIMITED - November 01, 2019

Source: https://www.globalkeysolutions.net/records/483/tentamus-india-private-limited/cb22d27b-63e6-4961-aaf8-d86fb41617f6

> FDA 483 for TENTAMUS INDIA PRIVATE LIMITED on November 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TENTAMUS INDIA PRIVATE LIMITED
- Inspection Date: 2019-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Megsan Labs Private Limited, a contract testing laboratory in Hyderabad, India, was cited for significant deficiencies in its laboratory control mechanisms and personnel adequacy. The inspection revealed failures in contemporaneous documentation, including blank spaces in records, missing signatures, and incomplete information for reagents and standards. Additionally, the firm was found to have an inadequate number of qualified personnel, leading to a high percentage of late samples in their LIMS.

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## Related Officers

- [June P. Page](https://www.globalkeysolutions.net/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
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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