1148890
Bruno Independent Living Aids, Inc. — FEI 1000116427
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oconomowoc, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |