FDA Inspection 811408 — Bruno Independent Living Aids, Inc.
The FDA completed an inspection of Bruno Independent Living Aids, Inc. on December 20, 2012 in Oconomowoc, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |