FDA Inspection 1291728 — APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY
The FDA completed an inspection of APEX (GUANGZHOU) TOOLS & ORTHOPEDICS COMPANY on October 30, 2025 in Guangzhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Guangzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3696 | 21 CFR 820.100(b) | Documentation |