FDA inspection
Contec Medical Systems Co., Ltd.: FDA inspection ending Jun 12, 2025
FDA inspection 1274346 · Official Action Indicated (OAI) · Qinhuangdao
Key facts
| Inspection ID | 1274346 |
|---|---|
| Firm | Contec Medical Systems Co., Ltd. |
| FEI number | 3006979678 |
| Address | Economic And, No. 112 Qinhuang West Street; Technical Development Zone |
| City | Qinhuangdao |
| Country | China |
| Fiscal year | 2025 |
| Inspection end date | Jun 12, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 717941 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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