FDA Inspection 1249760 — DELBio (Wujiang) Co., Ltd.
The FDA completed an inspection of DELBio (Wujiang) Co., Ltd. on Sep 12, 2024 in Suzhou. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 12, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Suzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |