FDA Inspection
RESIDEO LIFE CARE SOLUTIONS LLCRESIDEO LIFE CARE SOLUTIONS LLC – FDA Inspection, Nov 13, 2012
Record Details
This FDA Inspection record concerns RESIDEO LIFE CARE SOLUTIONS LLC, with an inspection on November 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 13, 2012
- Product Type
- Devices
View Company Profile
ID · 5a1c646b-3076-4af2-8c79-f0f2a0348362
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 806828
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RESIDEO LIFE CARE SOLUTIONS LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for RESIDEO LIFE CARE SOLUTIONS LLC
- FDA Inspection 632501 - 2009-12-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.