FDA Inspection
Nemschoff Chairs, Inc.Nemschoff Chairs, Inc. – FDA Inspection, Jul 25, 2014
Record Details
This FDA Inspection record concerns Nemschoff Chairs, Inc., with an inspection on July 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nemschoff Chairs, Inc.
- Inspection Date
- July 25, 2014
- Product Type
- Devices
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ID · ccae92af-7b90-42c1-9db9-a51592082394
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 889327
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(i)Software validation for automated processes
Showing 10 of 11 citations.
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Other FDA inspections of Nemschoff Chairs, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 15, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nemschoff Chairs, Inc.
- FDA Inspection 934538 - 2015-07-13
- FDA Inspection 773335 - 2012-03-15
- FDA Inspection 723110 - 2011-05-04
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