# FDA 483 - Aizant Drug Research Solutions Private Ltd. - November 14, 2025

Source: https://www.globalkeysolutions.net/records/483/aizant-drug-research-solutions-private-ltd/15b6ff35-0140-4042-8f71-829673898523

> FDA 483 for Aizant Drug Research Solutions Private Ltd. on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aizant Drug Research Solutions Private Ltd.
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Aizant Drug Research Solutions Pvt., Ltd. in Hyderabad, India, was inspected by the FDA from November 10-14, 2025. The inspection revealed two significant observations related to laboratory control procedures and data integrity. Specifically, the firm failed to consistently follow its SOP for repeating subject samples and inaccurately reported freeze/thaw cycles during sample analysis.

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## Related Officers

- [Sylvestre K. Dossou](https://www.globalkeysolutions.net/people/sylvestre-k-dossou/962f9277-7643-4f66-add9-1c3553fa1c14)

Company: https://www.globalkeysolutions.net/companies/aizant-drug-research-solutions-private-ltd/1a2d8dae-2eb4-4bc8-b36b-e94775bccd50

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8