FDA inspection
SynCardia Systems LLC: FDA inspection ending Oct 19, 2018
FDA inspection 1121472 · No Action Indicated (NAI) · Tucson, AZ
Key facts
| Inspection ID | 1121472 |
|---|---|
| Firm | SynCardia Systems LLC |
| FEI number | 3003761017 |
| Address | 1992 E Silverlake Rd |
| City | Tucson |
| State | AZ |
| ZIP | 85713-3865 |
| Fiscal year | 2019 |
| Inspection end date | Oct 19, 2018 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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