FDA Inspection
ASG Superconductors SpAASG Superconductors SpA – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns ASG Superconductors SpA, with an inspection on March 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ASG Superconductors SpA
- Inspection Date
- March 15, 2012
- Product Type
- Devices
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ID · 60126ce5-7c7b-45f7-afdd-d15dc8eb3623
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777406
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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