FDA Inspection
R2 Diagnostics, Inc.R2 Diagnostics, Inc. – FDA Inspection, Jan 31, 2018
Record Details
This FDA Inspection record concerns R2 Diagnostics, Inc., with an inspection on January 31, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6b6bad9a-85ac-4da9-b299-18326ae10f8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040085
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of R2 Diagnostics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for R2 Diagnostics, Inc.
- FDA Inspection 1159391 - 2021-12-09
- FDA Inspection 936833 - 2015-08-04
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