Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3018815311.
Observations2
Issue DateFebruary 06, 2026
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Axsome Therapeutics, Inc.
Location
New York, New York
FEI Number
3018815311
Product Type
Drugs
Issue Date
February 06, 2026
Country
United States
Inspection History, 2021 to 2026
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist