FDA Inspection 1032160 — China Surgical Dressing Center Co., Ltd.
The FDA completed an inspection of China Surgical Dressing Center Co., Ltd. on November 9, 2017 in Changhua City. 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
- November 9, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Changhua City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |