Company
United StatesSupernus Pharmaceuticals, Inc., Rockville, MD – FDA Inspections
Inspection records and compliance data for Supernus Pharmaceuticals, Inc. in Rockville, Maryland. 6 FDA inspections on record, 1 Form 483, last inspected July 31, 2025.
Company Profile
This profile covers Supernus Pharmaceuticals, Inc. based in Rockville, Maryland, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected June 19, 2014. Last inspected July 31, 2025.
Most cited issue areas
- Late submission of quarterly safety reports1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 31, 2025 | NAI | Human Drugs · Drug Quality Assurance | 1280332 |
| October 10, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1109126 |
| July 10, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1098819 |
| February 3, 2017 | VAI | Human Drugs · Bioresearch Monitoring | 1010922 |
| February 23, 2015 | NAI | Human Drugs · Drug Quality Assurance | 915034 |
| June 19, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 888135 |
FDA documents
Form 483s (1)
EIRs (1)
Other FDA documents (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Supernus Pharmaceuticals, Inc.
FEI Number
3005209462
Address
9715 Key West Ave, Rockville, Maryland 20850, United States
Country
United States
ID: eff1a996-667f-4888-9fd8-50ca50265d74