FDA inspection
Western / Scott Fetzer Company: FDA inspection ending Aug 8, 2018
FDA inspection 1134000 · Voluntary Action Indicated (VAI) · Avon Lake, OH
Key facts
| Inspection ID | 1134000 |
|---|---|
| Firm | Western / Scott Fetzer Company |
| FEI number | 1526292 |
| Address | 33672 Pin Oak Pkwy |
| City | Avon Lake |
| State | OH |
| ZIP | 44012-2322 |
| Fiscal year | 2018 |
| Inspection end date | Aug 8, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
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