FDA inspection
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.: FDA inspection ending Nov 22, 2024
FDA inspection 1258985 · Official Action Indicated (OAI) · Shenzhen
Key facts
| Inspection ID | 1258985 |
|---|---|
| Firm | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. |
| FEI number | 3008457078 |
| Address | Pingshan, New District 16 Kengzizhen Longgang |
| City | Shenzhen |
| Country | China |
| Fiscal year | 2025 |
| Inspection end date | Nov 22, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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