FDA inspection
Amgen Manufacturing Limited: FDA inspection ending May 8, 2019
FDA inspection 1093715 · Official Action Indicated (OAI) · Juncos, PR
Key facts
| Inspection ID | 1093715 |
|---|---|
| Firm | Amgen Manufacturing Limited |
| FEI number | 1000110364 |
| Address | Rd 31 Km 24.6 |
| City | Juncos |
| State | PR |
| ZIP | 777 |
| Fiscal year | 2019 |
| Inspection end date | May 8, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data