FDA Inspection 871892 — Tianjin New Bay Bioresearch Co., Ltd.
The FDA completed an inspection of Tianjin New Bay Bioresearch Co., Ltd. on March 6, 2014 in Tianjin. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 6, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tianjin (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |