FDA Inspection 799748 — Podo Xingda Medical Co., Ltd.
The FDA completed an inspection of Podo Xingda Medical Co., Ltd. on August 16, 2012 in Dongli. 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
- August 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dongli (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3241 | 21 CFR 820.72(b)(1) | Calibration standard traceability |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 4189 | 21 CFR 820.198(a) | General |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |