FDA Inspection 890159 — Cobes Industries (Hefei) Co., Ltd.
The FDA completed an inspection of Cobes Industries (Hefei) Co., Ltd. on July 17, 2014 in Hefei. 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
- July 17, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hefei (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |