FDA inspection
Spectra Medical Devices, Llc: FDA inspection ending May 4, 2012
FDA inspection 779912 · Voluntary Action Indicated (VAI) · Wilmington, MA
Key facts
| Inspection ID | 779912 |
|---|---|
| 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 | 2012 |
| Inspection end date | May 4, 2012 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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