# FDA 483 - Alok Gambhir, MD, PhD. - October 01, 2025

Source: https://www.globalkeysolutions.net/records/483/alok-gambhir-md-phd/8a3326a0-fcf0-48a4-8675-b867ca5ea555

> FDA 483 for Alok Gambhir, MD, PhD. on October 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alok Gambhir, MD, PhD.
- Inspection Date: 2025-10-01
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Alok Gambhir, MD, PhD, a clinical investigator in Atlanta, GA, revealed significant deficiencies in the conduct of clinical trials. Observations included failures in obtaining proper informed consent, ensuring sub-investigator agreements were signed before procedures, and timely reporting of adverse device effects to the sponsor. These findings indicate a need for improved adherence to regulatory requirements for human subject protection and investigational plan execution.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.globalkeysolutions.net/companies/alok-gambhir-md-phd/add87071-37ef-44d5-b514-5ea258ba7841

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7