FDA Inspection
Ascensia Diabetes Cares US Inc.Ascensia Diabetes Cares US Inc. – FDA Inspection, Sep 18, 2015
Record Details
This FDA Inspection record concerns Ascensia Diabetes Cares US Inc., with an inspection on September 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 18, 2015
- Product Type
- Devices
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ID · e098e7fe-a6b9-4842-a0ef-620463ed38b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943035
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.40Sponsors" general responsibilities
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Other FDA inspections of Ascensia Diabetes Cares US Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 3, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 11, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 28, 2013 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 8, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ascensia Diabetes Cares US Inc.
- FDA Inspection 969376 - 2016-03-02
- FDA Inspection 905806 - 2014-12-03
- FDA Inspection 839982 - 2013-07-11
- FDA Inspection 828427 - 2013-03-28
- FDA Inspection 685400 - 2010-11-08
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