FDA Inspection
Vivosonic Inc.Vivosonic Inc. – FDA Inspection, Feb 9, 2012
Record Details
This FDA Inspection record concerns Vivosonic Inc., with an inspection on February 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vivosonic Inc.
- Inspection Date
- February 9, 2012
- Product Type
- Devices
View Company Profile
ID · 01463841-38b1-4c92-b7ad-291f81c2ebe1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770694
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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