FDA Inspection
Sunrise Medical (US) LLCSunrise Medical (US) LLC – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Sunrise Medical (US) LLC, with an inspection on June 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · b6ee793a-cd87-49fa-90d6-73c8e2a734f5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1014294
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Sunrise Medical (US) LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sunrise Medical (US) LLC
- FDA Inspection 976332 - 2016-05-06
- 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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