FDA Inspection
Sonablate Corp.Sonablate Corp. – FDA Inspection, Aug 2, 2022
Record Details
This FDA Inspection record concerns Sonablate Corp., with an inspection on August 2, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sonablate Corp.
- Inspection Date
- August 2, 2022
- Product Type
- Devices
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ID · 25b6b6fb-9f5a-4d04-8468-472053462bc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1176147
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Sonablate Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2017 | 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 1032390 - 2017-11-29
- FDA Inspection 874159 - 2014-03-26
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