FDA Inspection 889327 — Nemschoff Chairs, Inc.
The FDA completed an inspection of Nemschoff Chairs, Inc. on July 25, 2014 in Sheboygan, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sheboygan, WI (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 |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |