FDA inspection
Grams Medical Inc.: FDA inspection ending Nov 29, 2016
FDA inspection 998842 · Official Action Indicated (OAI) · Costa Mesa, CA
Key facts
| Inspection ID | 998842 |
|---|---|
| Firm | Grams Medical Inc. |
| FEI number | 2021743 |
| Address | 2443 Norse Ave |
| City | Costa Mesa |
| State | CA |
| ZIP | 92627 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Nov 29, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: 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