FDA inspection
Karl Storz Endovision, Inc.: FDA inspection ending Oct 22, 2015
FDA inspection 947594 · Official Action Indicated (OAI) · Charlton, MA
Key facts
| Inspection ID | 947594 |
|---|---|
| Firm | Karl Storz Endovision, Inc. |
| FEI number | 1221826 |
| Address | 91 Carpenter Hill Rd |
| City | Charlton |
| State | MA |
| ZIP | 01507 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Oct 22, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 10–99 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