FDA inspection
Newton Implant Systems, Inc.: FDA inspection ending Aug 18, 2025
FDA inspection 1278912 · Voluntary Action Indicated (VAI) · Vista, CA
Key facts
| Inspection ID | 1278912 |
|---|---|
| Firm | Newton Implant Systems, Inc. |
| FEI number | 3016784205 |
| Address | 440 S Melrose Dr Ste 202 |
| City | Vista |
| State | CA |
| ZIP | 92081 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Aug 18, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
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