FDA Inspection
Sunrise Medical (US) LLCSunrise Medical (US) LLC – FDA Inspection, May 6, 2016
Record Details
This FDA Inspection record concerns Sunrise Medical (US) LLC, with an inspection on May 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunrise Medical (US) LLC
- Inspection Date
- May 6, 2016
- Product Type
- Devices
View Company Profile
ID · c9afc721-5c89-4338-b22c-bc532a5d0c3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976332
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 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(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.180Availability
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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 |
| April 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 24, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 19, 2012 | VAI | 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 922468 - 2015-04-15
- FDA Inspection 901289 - 2014-10-24
- FDA Inspection 763293 - 2012-01-19
- FDA Inspection 661235 - 2010-05-17
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