Drug factory · FDA FEI 3009831352
Qilu Antibiotics Pharmaceutical Co., Ltd.
No.849 Dongjia Town, Licheng District, Jinan, China
Problems found, fixed voluntarily at FDA's last inspection, Jul 16, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2013: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cefazolin | Makes it and tests it | Apotex Corp. | 60505-6142, 60505-6143, 60505-6231 +2 |
| Cefepime | Makes it and tests it | Apotex Corp. | 60505-6144, 60505-6145, 60505-6146 +3 |
| Cefotaxime | Makes it, tests it, packages it and labels it | SteriMax Inc. | 21586-031 |
| Cefpodoxime | Makes the active ingredient | Sandoz Inc. | 0781-5438, 0781-5439 |
| Ceftriaxone | Makes it, makes the active ingredient, tests it, packages it and labels it | Apotex Corp., Hospira, Inc., Qilu Pharmaceutical Co., Ltd. | 60505-6148, 60505-6149, 60505-6150 +8 |
| Ertapenem | Makes it, tests it and labels it | Hikma Pharmaceuticals USA Inc., Qilu Antibiotics Pharmaceutical Co., Ltd. | 0143-9429, 51810-504 |
| Meropenem | Makes it, tests it and labels it | Hikma Pharmaceuticals USA Inc., Qilu Antibiotics Pharmaceutical Co., Ltd. | 0143-9430, 0143-9431, 51810-502 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 16, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 30, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 16, 2018 | No problems found | Drug Quality Assurance | — |
| Sep 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.