FDA inspection
Breas Medical, Inc.: FDA inspection ending Sep 28, 2018
FDA inspection 1120414 · Voluntary Action Indicated (VAI) · North Billerica, MA
Key facts
| Inspection ID | 1120414 |
|---|---|
| Firm | Breas Medical, Inc. |
| FEI number | 3010817335 |
| Address | 16 Esquire Rd |
| City | North Billerica |
| State | MA |
| ZIP | 01862-2527 |
| Fiscal year | 2018 |
| Inspection end date | Sep 28, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical 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