# FDA 483 - Aparna Kalyan, M.D. - February 18, 2025

Source: https://www.globalkeysolutions.net/records/483/aparna-kalyan-md/c164d9b3-c286-40b7-8ad9-40908ec3c9cb

> FDA 483 for Aparna Kalyan, M.D. on February 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aparna Kalyan, M.D.
- Inspection Date: 2025-02-18
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Aparna Kalyan, M.D. in Chicago, IL, a clinical investigator, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, safety laboratory tests were not performed for a subject across multiple study visits, and a subject received an incorrect dose of investigational product, leading to neutropenia.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)

Company: https://www.globalkeysolutions.net/companies/aparna-kalyan-md/b13a4163-f370-420a-b036-d98468d3b9b1

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669