FDA Inspection 1311202 — SunMed AP, Ltd.
The FDA completed an inspection of SunMed AP, Ltd. on March 5, 2026 in Zhuhai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zhuhai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 21469 | 21 CFR 807.40(a) | Failure to register |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23127 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer procedures not documented |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |