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

Source: https://www.keypedia.com/records/483/axsome-therapeutics-inc/ffa97223-889e-4da3-9e3e-8cde35c8d9bd

> 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: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Axsome Therapeutics, Inc. in New York, NY, revealed significant deficiencies in their conduct 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 adequate oversight in their clinical research operations.

## Related Documents

- [483 - 2026-02-06](https://www.keypedia.com/records/483/axsome-therapeutics-inc/cac8d33c-b337-4a4b-b724-23a82c6eb011)
- [EIR - 2026-07-01](https://www.keypedia.com/records/eir/axsome-therapeutics-inc/e0c886fc-82b4-4bab-accd-441d61bfea93)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961