FDA Inspection
QIAGEN Instruments AGQIAGEN Instruments AG – FDA Inspection, Jul 19, 2013
Record Details
This FDA Inspection record concerns QIAGEN Instruments AG, with an inspection on July 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- QIAGEN Instruments AG
- Inspection Date
- July 19, 2013
- Product Type
- Devices
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ID · 93a66d7c-b404-4d58-ad46-1ff0a5eeb0c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843989
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of QIAGEN Instruments AG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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