FDA inspection
Custom Smiles Sleep Department: FDA inspection ending Mar 18, 2022
FDA inspection 1165161 · Voluntary Action Indicated (VAI) · Kannapolis, NC
Key facts
| Inspection ID | 1165161 |
|---|---|
| Firm | Custom Smiles Sleep Department |
| FEI number | 3014945982 |
| Address | 2530 Lane St |
| City | Kannapolis |
| State | NC |
| ZIP | 28083 |
| Country | United States |
| Fiscal year | 2022 |
| Inspection end date | Mar 18, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 10–99 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