FDA Inspection 723110 — Nemschoff Chairs, Inc.
The FDA completed an inspection of Nemschoff Chairs, Inc. on May 4, 2011 in Sheboygan, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 4, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sheboygan, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |