FDA Inspection
Alken Inc.Alken Inc. – FDA Inspection, Jul 24, 2014
Record Details
This FDA Inspection record concerns Alken Inc., with an inspection on July 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alken Inc.
- Inspection Date
- July 24, 2014
- Product Type
- Devices
View Company Profile
ID · c2eb20c1-64dc-4916-8658-6b9f7680a4c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888714
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Alken Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 8, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Alken Inc.
- FDA Inspection 1027428 - 2017-09-12
- FDA Inspection 767900 - 2012-02-16
- FDA Inspection 583580 - 2009-05-08
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