FDA Inspection 1301534 — Axsome Therapeutics, Inc.
The FDA completed an inspection of Axsome Therapeutics, Inc. on February 6, 2026 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7557 | 21 CFR 312.56(b) | Notification of FDA of termination of investigator |