983195
Banyan Medical, LLC — FEI 3009770724
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |