Drug factory · FDA FEI 3012403297
Quagen Pharmaceuticals LLC
35 Fairfield Pl, West Caldwell, NJ, United States
No problems found at FDA's last inspection, Apr 17, 2026.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2020: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetaminophen and Butalbital | Makes it and packages it | Quagen Pharmaceuticals LLC | 70752-147, 70752-148 |
| Acetaminophen and Butalbital and Caffeine | Makes it and packages it | Quagen Pharmaceuticals LLC | 70752-141, 70752-142, 70752-144 |
| Acyclovir | Makes it and packages it | Aryeh Pharma corp | 85957-036 |
| Benztropine | Makes it and packages it | Quagen Pharmaceuticals LLC | 70752-123, 70752-124, 70752-125 |
| Cyproheptadine | Makes it and packages it | Quagen Pharmaceuticals LLC | 70752-232 |
| Glycopyrronium | Makes it and packages it | Quagen Pharmaceuticals LLC | 70752-108, 70752-109 |
| Levetiracetam | Makes it and packages it | Quagen Pharmaceuticals LLC | 70752-203 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 17, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 17, 2026 | No problems found | Drug Quality Assurance | — |
| May 9, 2023 | No problems found | Drug Quality Assurance | — |
| May 9, 2023 | No problems found | Drug Quality Assurance | — |
| Oct 26, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 26, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture; pack.