FDA Inspection
Sonablate Corp.Sonablate Corp. – FDA Inspection, Nov 29, 2017
Record Details
This FDA Inspection record concerns Sonablate Corp., with an inspection on November 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e85e4ea9-87bd-4627-b6a1-f1ce6098b935
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032390
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Sonablate Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Sonablate Corp.
- FDA Inspection 1176147 - 2022-08-02
- FDA Inspection 874159 - 2014-03-26
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