FDA Inspection
Wright Therapy Products, Inc.Wright Therapy Products, Inc. – FDA Inspection, Jun 1, 2015
Record Details
This FDA Inspection record concerns Wright Therapy Products, Inc., with an inspection on June 1, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 1, 2015
- Product Type
- Devices
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ID · f9b96af7-92bb-4e2f-90c5-c35a9b489c07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926621
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Wright Therapy Products, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wright Therapy Products, Inc.
- FDA Inspection 838640 - 2013-06-28
- FDA Inspection 739277 - 2011-08-18
- FDA Inspection 623425 - 2009-12-09
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