FDA inspection
Gentere Inc: FDA inspection ending Mar 19, 2004
FDA inspection 317705 · Official Action Indicated (OAI) · Willoughby, OH
Key facts
| Inspection ID | 317705 |
|---|---|
| Firm | Gentere Inc |
| FEI number | 1526450 |
| Address | 38320 Western Pkwy |
| City | Willoughby |
| State | OH |
| ZIP | 44094-7593 |
| Fiscal year | 2004 |
| Inspection end date | Mar 19, 2004 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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