FDA Inspection
R2 Diagnostics, Inc.R2 Diagnostics, Inc. – FDA Inspection, Aug 4, 2015
Record Details
This FDA Inspection record concerns R2 Diagnostics, Inc., with an inspection on August 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- R2 Diagnostics, Inc.
- Inspection Date
- August 4, 2015
- Product Type
- Devices
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ID · 1caab37b-2564-43d6-bb64-63d53795fa5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 936833
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| January 31, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for R2 Diagnostics, Inc.
- FDA Inspection 1159391 - 2021-12-09
- FDA Inspection 1040085 - 2018-01-31
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