FDA Inspection
Ulthera IncUlthera Inc – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns Ulthera Inc, with an inspection on July 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bf704cfb-cdfe-478b-b59c-bada010dcce2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060604
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ulthera Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2025 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 22, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 23, 2017 | Not classified | Atlanta District Office | |
| August 7, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ulthera Inc
- FDA Inspection 1290810 - 2025-10-28
- FDA Inspection 1209243 - 2023-06-22
- FDA Inspection 1103289 - 2019-09-18
- FDA Inspection 1029899 - 2017-06-23
- FDA Inspection 941155 - 2015-08-07
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