FDA inspection
AOMI PRECISION CO LTD: FDA inspection ending Jul 24, 2025
FDA inspection 1278397 · Official Action Indicated (OAI) · Niigata
Key facts
| Inspection ID | 1278397 |
|---|---|
| Firm | AOMI PRECISION CO LTD |
| FEI number | 3015217553 |
| Address | Minami 787, Shimomagaridori; |
| City | Niigata |
| Fiscal year | 2025 |
| Inspection end date | Jul 24, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Product Evaluation: Medical 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