FDA Inspection 837589 — Vincent Medical (Dong Guan) Manufacturing Co., Ltd.
The FDA completed an inspection of Vincent Medical (Dong Guan) Manufacturing Co., Ltd. on May 30, 2013 in Dongguan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dongguan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | 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 |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |