FDA Inspection
Ascensia Diabetes Care U.S. Inc.Ascensia Diabetes Care U.S. Inc. – FDA Inspection, Jan 10, 2017
Record Details
This FDA Inspection record concerns Ascensia Diabetes Care U.S. Inc., with an inspection on January 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy S. Graf (Issuing Officer)
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ID · e9f3a6ec-6915-4982-9a4e-81b53fafb4f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997724
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ascensia Diabetes Care U.S. Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 12, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ascensia Diabetes Care U.S. Inc.
- FDA Inspection 898407 - 2014-09-23
- FDA Inspection 790809 - 2012-07-20
- FDA Inspection 651127 - 2010-03-12
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