FDA Inspection
Ascensia Diabetes Cares US Inc.Ascensia Diabetes Cares US Inc. – FDA Inspection, Jun 24, 2010
Record Details
This FDA Inspection record concerns Ascensia Diabetes Cares US Inc., with an inspection on June 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 24, 2010
- Product Type
- Drugs
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ID · f8e85916-0e5b-46aa-8e3b-5d6d545a3cb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672732
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
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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 |
| September 18, 2015 | VAI | Center for Devices and Radiological Health | 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 |
Other documents for Ascensia Diabetes Cares US Inc.
- FDA Inspection 969376 - 2016-03-02
- FDA Inspection 943035 - 2015-09-18
- FDA Inspection 905806 - 2014-12-03
- FDA Inspection 839982 - 2013-07-11
- FDA Inspection 828427 - 2013-03-28
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