FDA Inspection
Sunrise Medical US, LLCSunrise Medical US, LLC – FDA Inspection, Feb 9, 2009
Record Details
This FDA Inspection record concerns Sunrise Medical US, LLC, with an inspection on February 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunrise Medical US, LLC
- Inspection Date
- February 9, 2009
- Product Type
- Devices
View Company Profile
ID · 16d17883-f756-4ff5-a8fc-44fa9909faa2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566043
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.80(d)(3)No release signature
- 21 CFR 820.80(d)(4)No release authorization date
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Other FDA inspections of Sunrise Medical US, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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