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 NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |