FDA Inspection 954880 — Jiangsu Suyun Medical Materials Co., Ltd.
The FDA completed an inspection of Jiangsu Suyun Medical Materials Co., Ltd. on December 4, 2015 in Lianyungang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lianyungang (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |