PMDA inspection
Rottendorf Pharma GmbH/Am Fleigendahl
PMDA inspection 5130608039194 · Germany · Suitable
Key facts
| Control number | 5130608039194 |
|---|---|
| Manufacturing site | Rottendorf Pharma GmbH/Am Fleigendahl |
| Location | Am Fleigendahl 3, D-59320 Ennigerloh, Germany |
| Country | Germany |
| Product type | Pharmaceuticals |
| Application type | Complete Change |
| Inspection method | Remote |
| Inspection month | Jul 1, 2025 |
| Result | Suitable |
| Result notified | Jul 25, 2025 |
| PMDA registration | AG21300206 |
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