Drug factory · FDA FEI 3009268752
Amneal Pharmaceuticals, LLC
1 Murray Rd, East Hanover, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 28, 2018.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Folic Acid | Packages it | Amneal Pharmaceuticals | 65162-361 |
| Gabapentin | Packages it | Amneal Pharmaceuticals | 53746-101, 53746-102, 53746-103 |
| Ibuprofen | Packages it | Amneal Pharmaceuticals | 53746-464, 53746-465, 53746-466 |
| Metformin | Packages it and repackages it | Amneal Pharmaceuticals | 53746-178, 53746-179 |
| Naproxen | Packages it | Amneal Pharmaceuticals | 53746-188, 53746-189, 53746-190 |
| Pilocarpine | Packages it and repackages it | Amneal Pharmaceuticals | 0115-5911, 0115-5922 |
| Pyridostigmine | Packages it | Amneal Pharmaceuticals | 0115-1404 |
| Ranitidine | Packages it | Amneal Pharmaceuticals | 53746-253, 53746-254 |
| Tramadol | Packages it | Amneal Pharmaceuticals | 65162-627, 69238-2348 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 28, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 21, 2017 | No problems found | Drug Quality Assurance | — |
| May 30, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: pack.