FDA Inspection
SonoCine Inc.SonoCine Inc. – FDA Inspection, Sep 11, 2017
Record Details
This FDA Inspection record concerns SonoCine Inc., with an inspection on September 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5917b580-99a3-4045-9f19-3e1559b65c29
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024900
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of SonoCine Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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