FDA Inspection
Elexxion AGElexxion AG – FDA Inspection, Feb 16, 2012
Record Details
This FDA Inspection record concerns Elexxion AG, with an inspection on February 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elexxion AG
- Inspection Date
- February 16, 2012
- Product Type
- Devices
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ID · e58eb232-3d90-4f01-98f7-504a414d264b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772059
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(i)Software validation for automated processes
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