FDA Inspection
Viant AS&O Holdings, LLCViant AS&O Holdings, LLC – FDA Inspection, Oct 5, 2017
Record Details
This FDA Inspection record concerns Viant AS&O Holdings, LLC, with an inspection on October 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 95d2df31-2810-44c3-ac83-a36d7af7c6e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027975
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Viant AS&O Holdings, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 23, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Viant AS&O Holdings, LLC
- FDA Inspection 1221686 - 2023-10-27
- FDA Inspection 1131915 - 2020-10-23
- FDA Inspection 631322 - 2009-11-20
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