FDA Inspection
Qiagen Sciences LLCQiagen Sciences LLC – FDA Inspection, Feb 21, 2018
Record Details
This FDA Inspection record concerns Qiagen Sciences LLC, with an inspection on February 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Daniel R. Tammariello (Issuing Officer)
- James M. Simpson (Company Rep)
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ID · 927887c3-140c-4215-adb8-54ed330c3777
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1041732
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
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Other FDA inspections of Qiagen Sciences LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2018 | Not classified | Baltimore District Office | |
| December 19, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 5, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Qiagen Sciences LLC
- FDA Inspection 1146298 - 2021-07-16
- FDA Inspection 1082388 - 2018-04-13
- FDA Inspection 995735 - 2016-12-19
- FDA Inspection 958088 - 2016-02-05
- FDA Inspection 919610 - 2015-03-26
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