Company
United StatesR2 Diagnostics, Inc., South Bend, IN – FDA Inspections
Inspection records and compliance data for R2 Diagnostics, Inc. in South Bend, Indiana. 3 FDA inspections on record, 1 Form 483, last inspected December 09, 2021.
Company Profile
This profile covers R2 Diagnostics, Inc. based in South Bend, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 4, 2015. Last inspected December 9, 2021.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate2 inspections
- Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 9, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1159391 |
| January 31, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1040085 |
| August 4, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 936833 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
R2 Diagnostics, Inc.
FEI Number
3000210416
Address
1801 Commerce Dr, South Bend, Indiana 46628, United States
Country
United States
ID: b89a8ca1-755b-4e71-afc5-b03026a97d4a