FDA inspection
Rockwell Medical, Inc: FDA inspection ending Apr 3, 2015
FDA inspection 914050 · Official Action Indicated (OAI) · Wixom, MI
Key facts
| Inspection ID | 914050 |
|---|---|
| Firm | Rockwell Medical, Inc |
| FEI number | 3001236991 |
| Address | 30142 S Wixom Rd |
| City | Wixom |
| State | MI |
| ZIP | 48393 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Apr 3, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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