FDA Inspection
Alien TechnikAlien Technik – FDA Inspection, Feb 7, 2013
Record Details
This FDA Inspection record concerns Alien Technik, with an inspection on February 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alien Technik
- Inspection Date
- February 7, 2013
- Product Type
- Devices
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ID · 757d91b1-eab4-46d1-b99c-be06d64a63d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 819441
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Alien Technik
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alien Technik
- FDA Inspection 958330 - 2016-02-05
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