811408
Bruno Independent Living Aids, Inc. — FEI 1000116427
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2012
- Fiscal Year
- 2013
- 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 |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 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 |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |