# FDA 483 - Adarsh Daswani, M.D. - October 29, 2021

Source: https://www.keypedia.com/records/483/adarsh-daswani-md/19fbb1c1-e3f3-4cd1-8922-f8ac3bc2c1c9

> FDA 483 for Adarsh Daswani, M.D. on October 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Adarsh Daswani, M.D.
- Inspection Date: 2021-10-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 was issued to Adarsh Daswani, M.D., following an inspection that revealed significant deficiencies in the conduct and supervision of a clinical investigation. The inspection found failures in investigator oversight, adherence to the investigational plan, maintenance of accurate case histories, and proper accountability for investigational drug disposition. These issues indicate a lack of control over critical aspects of the clinical trial.

## Related Documents

- [WARNING_LETTER - 2021-10-29](https://www.keypedia.com/records/warning_letter/adarsh-daswani-md/bea0f9ad-eb57-4c12-a9c1-444b238aa113)
- [483 - 2025-02-07](https://www.keypedia.com/records/483/adarsh-daswani-md/a60be296-50a2-404d-ab90-b68d08937edf)

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)
- [issuing_officer](https://www.keypedia.com/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)

Company: https://www.keypedia.com/companies/adarsh-daswani-md/8a9b25da-7ec0-49dd-83d1-4a5606afdcfc

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6