# FDA 483 - Cliantha Research Limited - April 17, 2026

Source: https://www.keypedia.com/records/483/cliantha-research-limited/961322eb-f7bc-44a9-919c-b35305525671

> FDA 483 for Cliantha Research Limited on April 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cliantha Research Limited
- Inspection Date: 2026-04-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Cliantha Research Limited's Biopharmaceutics Analytical and Clinical Facility in Ahmedabad, India, revealed significant deficiencies across multiple areas. The firm failed to consistently investigate internal standard variations, maintain proper source documentation, and account for missing sample volumes. Additionally, the quality unit did not perform adequate laboratory investigations, and legally effective informed consent was not obtained from subjects.

## Related Documents

- [483 - 2026-04-17](https://www.keypedia.com/records/483/cliantha-research-limited/625b612e-933a-4eda-9716-729643a5725e)

## Related Officers

- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)
- [issuing_officer](https://www.keypedia.com/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)
- [issuing_officer](https://www.keypedia.com/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)
- [Anna M. Brannen](https://www.keypedia.com/people/anna-m-brannen/b8513ae4-9182-4024-94e4-dea1da4341be)

Company: https://www.keypedia.com/companies/cliantha-research-limited/91c22ac4-54a5-49a2-b630-fff41ae1f11d

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