FDA Inspection
Viant Medical, Inc.Viant Medical, Inc. – FDA Inspection, Nov 22, 2019
Record Details
This FDA Inspection record concerns Viant Medical, Inc., with an inspection on November 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Viant Medical, Inc.
- Inspection Date
- November 22, 2019
- Product Type
- Devices
View Company Profile
ID · f827b192-6609-46b7-8144-b0c45d0ce5b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1114529
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Viant Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Viant Medical, Inc.
- FDA Inspection 1229768 - 2024-02-16
- FDA Inspection 779891 - 2012-05-09
- FDA Inspection 649846 - 2010-03-03
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