FDA inspection
Intersurgical Medical Apparatus (Changzhou) Co., Ltd.: FDA inspection ending Aug 28, 2025
FDA inspection 1281374 · Voluntary Action Indicated (VAI) · Changzhou
Key facts
| Inspection ID | 1281374 |
|---|---|
| Firm | Intersurgical Medical Apparatus (Changzhou) Co., Ltd. |
| FEI number | 3015168843 |
| Address | No. 1011 Liaohe Road, Xuejiazhen Xinbei District |
| City | Changzhou |
| Country | China |
| Fiscal year | 2025 |
| Inspection end date | Aug 28, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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