FDA inspection
Spectra Medical Devices, Llc: FDA inspection ending Apr 25, 2024
FDA inspection 1237163 · Voluntary Action Indicated (VAI) · Wilmington, MA
Key facts
| Inspection ID | 1237163 |
|---|---|
| Firm | Spectra Medical Devices, Llc |
| FEI number | 3000204727 |
| Address | 299 Ballardvale St Ste 1 |
| City | Wilmington |
| State | MA |
| ZIP | 01887 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Apr 25, 2024 |
| 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