PMDA inspection
Koga Isotope Co., Ltd.
PMDA inspection 5130708019562 · Japan · Suitable
Key facts
| Control number | 5130708019562 |
|---|---|
| Manufacturing site | Koga Isotope Co., Ltd. |
| Location | 53-6 Jimbo, Koka-cho, Koka-shi, Shiga Prefecture |
| Country | Japan |
| Product type | Pharmaceuticals |
| Application type | Complete Change |
| Inspection method | On-Site |
| Inspection month | Sep 1, 2025 |
| Result | Suitable |
| Result notified | Nov 20, 2025 |
| PMDA registration | 25AZ200011 |
About PMDA GMP inspections (Japan)
Japan's PMDA conducts GMP and QMS inspections of domestic and foreign manufacturing sites that supply the Japanese market.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan