# FDA 483 - Axsome Therapeutics, Inc. - February 06, 2026

Source: https://www.keypedia.com/records/483/axsome-therapeutics-inc/cac8d33c-b337-4a4b-b724-23a82c6eb011

> FDA 483 for Axsome Therapeutics, Inc. on February 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Axsome Therapeutics, Inc.
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Axsome Therapeutics, Inc. in New York, NY, revealed significant deficiencies in their oversight of clinical trials. The firm failed to notify the FDA of an investigator's termination for cause and did not ensure studies were conducted according to protocol and monitoring plans. These issues indicate a lack of proper control over clinical trial conduct and documentation.

## Related Documents

- [483 - 2026-02-06](https://www.keypedia.com/records/483/axsome-therapeutics-inc/ffa97223-889e-4da3-9e3e-8cde35c8d9bd)
- [EIR - 2026-07-01](https://www.keypedia.com/records/eir/axsome-therapeutics-inc/e0c886fc-82b4-4bab-accd-441d61bfea93)

## Related Officers

- [Roberto A. Dookhan](https://www.keypedia.com/people/roberto-a-dookhan/01c2225f-a885-4421-9967-da323ce55cd8)
- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)
- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)

Company: https://www.keypedia.com/companies/axsome-therapeutics-inc/0bc3d1e2-dfe0-47ba-b144-4248f1fdfdf0

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d