Company
SwitzerlandQIAGEN Instruments AG, Hombrechtikon, Switzerland – FDA Inspections
Inspection records and compliance data for QIAGEN Instruments AG in Hombrechtikon. 3 FDA inspections on record, last inspected January 14, 2016.
Company Profile
This profile covers QIAGEN Instruments AG based in Hombrechtikon, Switzerland.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 19, 2013. Last inspected January 14, 2016.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Investigation of device failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 14, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 957347 |
| October 16, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 899915 |
| July 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 843989 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
QIAGEN Instruments AG
FEI Number
3005621256
Address
Garstligweg 8, Hombrechtikon, Switzerland
Country
Switzerland
ID: a40c761e-d171-4981-ad0c-56b7d649af24