FDA inspection
BCG Medical Inc: FDA inspection ending Sep 13, 2018
FDA inspection 1065934 · Voluntary Action Indicated (VAI) · Laguna Niguel, CA
Key facts
| Inspection ID | 1065934 |
|---|---|
| Firm | BCG Medical Inc |
| FEI number | 3009380895 |
| Address | 23052 Andria Pl |
| City | Laguna Niguel |
| State | CA |
| ZIP | 92677 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Sep 13, 2018 |
| 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