Drug factory · FDA FEI 3005209462
Supernus Pharmaceuticals Inc
9715 Key West Ave, Rockville, MD, United States
No problems found at FDA's last inspection, Jul 31, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2014: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxcarbazepine | Tests it | Ajanta Pharma USA Inc. | 27241-304, 27241-305, 27241-306 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 31, 2025 | No problems found | Drug Quality Assurance | — |
| Oct 10, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 10, 2019 | No problems found | Bioresearch Monitoring | — |
| Feb 3, 2017 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Feb 23, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 19, 2014 | No problems found | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 3, 2017 inspection
- Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
Registered with FDA for: analysis.