FDA Inspection 1007157 — Aaxis Medical Products (Suzhou) Co., Ltd.
The FDA completed an inspection of Aaxis Medical Products (Suzhou) Co., Ltd. on March 2, 2017 in Suzhou. 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
- March 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |