Drug factory · FDA FEI 3008822486
Delcath Systems, Inc.
95 Park Road, Queensbury, NY, United States
No problems found at FDA's last inspection, Sep 11, 2026.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2025: 2 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Melphalan and Sodium Cation | Makes it | Delcath Systems, Inc. | 75833-601 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 11, 2026 | No problems found | Bioresearch Monitoring | — |
| Apr 9, 2025 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: manufacture.