FDA inspection
Acera Surgical, Inc.: FDA inspection ending Dec 5, 2024
FDA inspection 1255818 · Voluntary Action Indicated (VAI) · Maryland Heights, MO
Key facts
| Inspection ID | 1255818 |
|---|---|
| Firm | Acera Surgical, Inc. |
| FEI number | 3027386220 |
| Address | 11825 Adie Rd |
| City | Maryland Heights |
| State | MO |
| ZIP | 63043 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Dec 5, 2024 |
| 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