FDA Inspection
Sunrise Medical (US) LLCSunrise Medical (US) LLC – FDA Inspection, May 17, 2010
Record Details
This FDA Inspection record concerns Sunrise Medical (US) LLC, with an inspection on May 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunrise Medical (US) LLC
- Inspection Date
- May 17, 2010
- Product Type
- Devices
View Company Profile
ID · 07bea56f-a4ff-4e1a-8470-cb26becf2916
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661235
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.22Quality audit corrective action, reaudits {see also 820.100}
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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 |
| January 19, 2012 | 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 763293 - 2012-01-19
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