FDA Inspection
Ultrasonic Services, Inc.Ultrasonic Services, Inc. – FDA Inspection, Mar 10, 2017
Record Details
This FDA Inspection record concerns Ultrasonic Services, Inc., with an inspection on March 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2dbe8b35-4fd5-483a-9778-9603668b7bb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003959
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ultrasonic Services, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ultrasonic Services, Inc.
- FDA Inspection 1158756 - 2021-12-10
- FDA Inspection 1064393 - 2018-08-27
- FDA Inspection 966110 - 2016-03-30
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