Company
United StatesAscensia Diabetes Care U.S. Inc., Mishawaka, IN – FDA Inspections
Inspection records and compliance data for Ascensia Diabetes Care U.S. Inc. in Mishawaka, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected January 10, 2017.
Company Profile
This profile covers Ascensia Diabetes Care U.S. Inc. based in Mishawaka, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 12, 2010. Last inspected January 10, 2017.
Most cited issue areas
- Records of complaint investigation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 10, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 997724 |
| September 23, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 898407 |
| July 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 790809 |
| March 12, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 651127 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
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Company Information
Name
Ascensia Diabetes Care U.S. Inc.
FEI Number
1826988
Address
430 S Beiger St, Mishawaka, Indiana 46544, United States
Country
United States
ID: 6ce959e6-533d-4fe5-97ac-0419b2827659