FDA Inspection
SUPERSONIC IMAGINESUPERSONIC IMAGINE – FDA Inspection, Mar 7, 2024
Record Details
This FDA Inspection record concerns SUPERSONIC IMAGINE, with an inspection on March 7, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5e4f62f4-76db-452e-894d-7374c83f48a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232785
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SUPERSONIC IMAGINE
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 6, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SUPERSONIC IMAGINE
- FDA Inspection 1063777 - 2018-07-26
- FDA Inspection 905898 - 2014-11-06
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