# Advity Research Private, Limited – FDA 483, Mar 15, 2024

Source: https://www.keypedia.com/records/483/advity-research-private-limited/ebabd9ed-a366-4a4d-aedb-c128ae02bf3d

> FDA 483 for Advity Research Private, Limited on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advity Research Private, Limited
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Advity Research Pvt., Ltd. in Kukatpally, India, a clinical and bioanalytical biopharmaceutical research facility, revealed a significant issue regarding informed consent. The firm failed to meet general requirements for informed consent, specifically by including language in their forms that did not minimize the possibility of coercion or undue influence. This observation indicates a moderate severity issue related to subject protection in clinical trials.

## Related Officers

- [Dawn C. Olenjack](https://www.keypedia.com/people/dawn-c-olenjack/b5a18d10-cd4b-405e-9016-8f5274a33000)

Company: https://www.keypedia.com/companies/advity-research-private-limited/b2e3a586-ef59-4d9d-8eb0-8330ba6cb608

Office: https://www.keypedia.com/offices/fda-district-office-silver-springs-maryland/88352440-432a-426b-ad8b-f768d4460a19