Drug factory · FDA FEI 3008861605
Amneal Pharmaceuticals, LLC
1 New England Ave Bldg A, Piscataway, NJ, United States
No problems found at FDA's last inspection, Apr 30, 2026.
No Action Indicated: inspectors found no objectionable conditions.
16 drug inspections on record since 2013: 7 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acyclovir | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-835 |
| Clobetasol | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1532 |
| Dapsone | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-339 |
| Estradiol | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-126, 65162-148, 65162-149 +7 |
| Ethinyl Estradiol and Etonogestrel | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-469 |
| Ethinyl Estradiol and Norelgestromin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-358, 69238-1521 |
| Lidocaine | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-791, 65162-918 |
| Nitrofurantoin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-478 |
| Posaconazole | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1476 |
| Ritonavir | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-061 |
| Rivastigmine | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-749, 65162-825, 65162-826 |
| Scopolamine | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1662 |
| Testosterone | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 69238-1013 |
| Tobramycin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-914 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 30, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2026 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2025 | No problems found | Bioresearch Monitoring | — |
| Mar 28, 2025 | No problems found | Bioresearch Monitoring | — |
| Nov 21, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 19, 2018 | No problems found | Bioresearch Monitoring | — |
| Oct 19, 2018 | No problems found | Bioresearch Monitoring | — |
| Feb 19, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 19, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 23, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 23, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 26, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 26, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.