FDA inspection
Gentell, Inc: FDA inspection ending Aug 25, 2015
FDA inspection 938404 · Official Action Indicated (OAI) · Bristol, PA
Key facts
| Inspection ID | 938404 |
|---|---|
| Firm | Gentell, Inc |
| FEI number | 1000522686 |
| Address | 2701 Bartram Rd |
| City | Bristol |
| State | PA |
| ZIP | 19007 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Aug 25, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 479251 |
At a glance
- 10–99 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