FDA Inspection
Ultrasonic Services, Inc.Ultrasonic Services, Inc. – FDA Inspection, Aug 27, 2018
Record Details
This FDA Inspection record concerns Ultrasonic Services, Inc., with an inspection on August 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 82de8b48-bf3d-4bbf-b491-b42a6cc0ce29
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064393
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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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 |
| March 10, 2017 | 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 1003959 - 2017-03-10
- FDA Inspection 966110 - 2016-03-30
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