FDA Inspection
Digisonics, Inc.Digisonics, Inc. – FDA Inspection, Dec 30, 2016
Record Details
This FDA Inspection record concerns Digisonics, Inc., with an inspection on December 30, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5d403689-b7e1-4d9a-86c1-a739b6a10d07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009627
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Digisonics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Digisonics, Inc.
- FDA Inspection 1249267 - 2024-08-12
- FDA Inspection 695460 - 2010-11-22
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