FDA inspection
AMO Puerto Rico Manufacturing, Inc.: FDA inspection ending Oct 16, 2015
FDA inspection 946268 · Voluntary Action Indicated (VAI) · Anasco, PR
Key facts
| Inspection ID | 946268 |
|---|---|
| Firm | AMO Puerto Rico Manufacturing, Inc. |
| FEI number | 2648035 |
| Address | Rd # 402 North Km 4.2, Industrial Park |
| City | Anasco |
| State | PR |
| ZIP | 00610 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Oct 16, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Project Evaluation: Devices |
| Product type | Devices |
At a glance
- 1–9 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