Drug factory · FDA FEI 3004330858
Shandong Luye Pharmaceutical Co., LTD.
No.15 Chuangye Road, Hi-tech Industrial Development Zone, , Yantai, China
No problems found at FDA's last inspection, May 14, 2024.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2024: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Paliperidone | Makes it, tests it, packages it and labels it | Shandong Luye Pharmaceutical Co., Ltd. | 72526-105, 72526-106, 72526-107 +3 |
| Risperidone | Makes it, tests it, packages it and labels it | Shandong Luye Pharmaceutical Co., Ltd. | 72526-102, 72526-103, 72526-104 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 14, 2024 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.