FDA inspection
SureTek Medical: FDA inspection ending Nov 10, 2015
FDA inspection 948473 · Official Action Indicated (OAI) · Greenville, SC
Key facts
| Inspection ID | 948473 |
|---|---|
| Firm | SureTek Medical |
| FEI number | 3005575604 |
| Address | 25B Maple Creek Cir |
| City | Greenville |
| State | SC |
| ZIP | 29607 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Nov 10, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 491438 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 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