FDA inspection
Kalitec Direct, LLC: FDA inspection ending Apr 13, 2017
FDA inspection 1008979 · Voluntary Action Indicated (VAI) · Sarasota, FL
Key facts
| Inspection ID | 1008979 |
|---|---|
| Firm | Kalitec Direct, LLC |
| FEI number | 3009165919 |
| Address | 865 Oviedo Blvd Ste 1017 |
| City | Sarasota |
| State | FL |
| ZIP | 34236 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Apr 13, 2017 |
| 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