FDA inspection
New Era Orthopaedics, LLc: FDA inspection ending Jun 11, 2018
FDA inspection 1056379 · Voluntary Action Indicated (VAI) · Lake Mary, FL
Key facts
| Inspection ID | 1056379 |
|---|---|
| Firm | New Era Orthopaedics, LLc |
| FEI number | 3010760160 |
| Address | 1011 Shadowmoss Cir |
| City | Lake Mary |
| State | FL |
| ZIP | 32746 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Jun 11, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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