FDA Inspection
Sunrise Medical (US) LLCSunrise Medical (US) LLC – FDA Inspection, Jan 19, 2012
Record Details
This FDA Inspection record concerns Sunrise Medical (US) LLC, with an inspection on January 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunrise Medical (US) LLC
- Inspection Date
- January 19, 2012
- Product Type
- Devices
View Company Profile
ID · c72241f3-fa73-41d6-9f11-55f1c4a635cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 763293
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Sunrise Medical (US) LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 6, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 24, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunrise Medical (US) LLC
- FDA Inspection 1014294 - 2017-06-15
- FDA Inspection 976332 - 2016-05-06
- FDA Inspection 922468 - 2015-04-15
- FDA Inspection 901289 - 2014-10-24
- FDA Inspection 661235 - 2010-05-17
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