FDA Inspection
R4 LLCR4 LLC – FDA Inspection, Mar 23, 2009
Record Details
This FDA Inspection record concerns R4 LLC, with an inspection on March 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- R4 LLC
- Inspection Date
- March 23, 2009
- Product Type
- Devices
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ID · b363a337-b3b4-4c32-8b42-9ff4d9d290df
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 568916
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of R4 LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for R4 LLC
- FDA Inspection 682103 - 2010-09-20
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