FDA inspection
Gentere Inc: FDA inspection ending Aug 21, 2003
FDA inspection 287736 · Official Action Indicated (OAI) · Willoughby, OH
Key facts
| Inspection ID | 287736 |
|---|---|
| Firm | Gentere Inc |
| FEI number | 1526450 |
| Address | 38320 Western Pkwy |
| City | Willoughby |
| State | OH |
| ZIP | 44094-7593 |
| Fiscal year | 2003 |
| Inspection end date | Aug 21, 2003 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No 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