FDA Inspection 1314104 — Jiangsu Suyun Medical Materials Co., Ltd.
The FDA completed an inspection of Jiangsu Suyun Medical Materials Co., Ltd. on April 10, 2026 in Lianyungang. 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
- April 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lianyungang (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 23114 | ISO 13485:2016 Clause 7.3.6 | Design and development verification not performed |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23196 | ISO 13485:2016 Clause 7.6(b) | Adjustment to measuring equipment was not performed or recorded |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |