FDA inspection
Blue Ocean Medical Products, LLC: FDA inspection ending Dec 23, 2014
FDA inspection 909485 · Voluntary Action Indicated (VAI) · Rochester, NY
Key facts
| Inspection ID | 909485 |
|---|---|
| Firm | Blue Ocean Medical Products, LLC |
| FEI number | 3009534277 |
| Address | 135 Calkins Rd Ste 600 |
| City | Rochester |
| State | NY |
| ZIP | 14623 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Dec 23, 2014 |
| 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