FDA inspection
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY: FDA inspection ending Jun 18, 2015
FDA inspection 938458 · Official Action Indicated (OAI) · Dongguan
Key facts
| Inspection ID | 938458 |
|---|---|
| Firm | DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY |
| FEI number | 3004829691 |
| Address | No 17 Banhu, Huang Jiang Town |
| City | Dongguan |
| Country | China |
| Fiscal year | 2015 |
| Inspection end date | Jun 18, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 481365 |
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