FDA inspection
Glottal Enterprises Inc.: FDA inspection ending Oct 18, 2012
FDA inspection 804076 · Official Action Indicated (OAI) · Syracuse, NY
Key facts
| Inspection ID | 804076 |
|---|---|
| Firm | Glottal Enterprises Inc. |
| FEI number | 1319182 |
| Address | 1201 E Fayette St Ste 15 |
| City | Syracuse |
| State | NY |
| ZIP | 13210 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Oct 18, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 380560 |
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