FDA inspection
Frantz Medical Development Ltd: FDA inspection ending Sep 24, 2018
FDA inspection 1066754 · Voluntary Action Indicated (VAI) · Mentor, OH
Key facts
| Inspection ID | 1066754 |
|---|---|
| Firm | Frantz Medical Development Ltd |
| FEI number | 1526605 |
| Address | 7740 Metric Dr |
| City | Mentor |
| State | OH |
| ZIP | 44060 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Sep 24, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 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