PMDA inspection
Amgen Manufacturing Limited LLC
PMDA inspection 5130608000487 · Puerto Rico (US) · Suitable
Key facts
| Control number | 5130608000487 |
|---|---|
| Manufacturing site | Amgen Manufacturing Limited LLC |
| Location | State Road 31, Kilometer 24.6 Juncos, Puerto Rico 00777 |
| Country | Puerto Rico (US) |
| Product type | Pharmaceuticals |
| Application type | Complete Change |
| Inspection method | On-Site |
| Inspection month | Apr 1, 2024 |
| Result | Suitable |
| Result notified | Jul 17, 2024 |
| PMDA registration | AG32400068 |
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