Drug factory · FDA FEI 3015917315
Shandong Xinhua Pharmaceutical Co., Ltd. FDF Plant
No. 1 Lutai Road, High-tech District, Zibo, China
No problems found at FDA's last inspection, Dec 8, 2023.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2023: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ibuprofen | Makes it | AiPing Pharmaceutical, Inc. | 11788-008, 11788-009, 11788-010 |
| Sevelamer | Makes it, tests it and packages it | AiPing Pharmaceutical, Inc., Shandong Xinhua Pharmaceutical Co., Ltd. | 11788-116, 58624-5001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 8, 2023 | No problems found | Drug Quality Assurance | — |
| Sep 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.