Drug factory · FDA FEI 3011266110
Haimen Pharma Inc.
No.163, Zhuhai Rd, Binjiang Street, Haimen District, Nantong, China
Problems found, fixed voluntarily at FDA's last inspection, Aug 25, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2020: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mesalamine | Makes it, tests it, packages it and labels it | Lannett Company, Inc. | 0527-3012 |
| Metformin | Makes it, tests it, packages it and labels it | AlignScience Pharma Inc. | 69948-001 |
| Paroxetine | Makes it, tests it, packages it and labels it | Sinotherapeutics Inc. | 69986-011, 69986-012, 69986-017 |
| Posaconazole | Makes it, tests it, packages it and labels it | Lannett Company, Inc. | 0527-2133 |
| Pregabalin | Makes it, tests it, packages it and labels it | Sinotherapeutics Inc. | 69986-013, 69986-014, 69986-015 |
| Propafenone | Makes it, tests it, packages it and labels it | Vitruvias Therapeutics, Inc. | 69680-130, 69680-131, 69680-132 |
| Quetiapine | Makes it, tests it, packages it and labels it | AlignScience Pharma Inc. | 69948-002, 69948-003 |
| Sevelamer | Makes it, tests it, packages it and labels it | Insignamedex LLC, Marp Pharma | 87367-266, 85898-101 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 25, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 10, 2020 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.