FDA inspection
Med Pen Concepts, LLC: FDA inspection ending Jun 14, 2023
FDA inspection 1209069 · Voluntary Action Indicated (VAI) · Woburn, MA
Key facts
| Inspection ID | 1209069 |
|---|---|
| Firm | Med Pen Concepts, LLC |
| FEI number | 3015602723 |
| Address | 800 W Cummings Park Ste 5650 |
| City | Woburn |
| State | MA |
| ZIP | 01801 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Jun 14, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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