FDA inspection
Henan Kangdi Medical Devices Co. Ltd: FDA inspection ending Mar 7, 2019
FDA inspection 1084134 · Official Action Indicated (OAI) · Zhoukou
Key facts
| Inspection ID | 1084134 |
|---|---|
| Firm | Henan Kangdi Medical Devices Co. Ltd |
| FEI number | 3009271465 |
| Address | Sme Pioneer Park, No. 4; 2nd Area |
| City | Zhoukou |
| Country | China |
| Fiscal year | 2019 |
| Inspection end date | Mar 7, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 587699 |
At a glance
- None 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