Ulthera Inc, Raleigh, NC – FDA Inspections

Inspection records and compliance data for Ulthera Inc in Raleigh, North Carolina. 11 FDA inspections on record (1 OAI), 1 Form 483, last inspected October 28, 2025.

Company Profile

This profile covers Ulthera Inc based in Raleigh, North Carolina, United States.

FDA Inspection History

FDA inspections: 11
OAI: 1
VAI: 2
NAI: 7
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected November 24, 2009. Last inspected October 28, 2025.

Most cited issue areas

Documentation1 inspection
Lack of or inadequate procedures1 inspection

FDA inspections (11)

Date	Result	FDA center(s)	Insp. #
October 28, 2025	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	1290810
June 22, 2023	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	1209243
September 18, 2019	NAI	Human Drugs · Bioresearch Monitoring	1103289
July 26, 2018	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1060604
June 23, 2017	Not classified	Medical Devices & Rad Health	1029899
August 7, 2015	NAI	Human Drugs · Bioresearch Monitoring	941155
January 26, 2015	NAI	Human Drugs · Drug Quality Assurance	912381
July 21, 2011	VAI	Medical Devices & Rad Health · Compliance: Devices	738168
September 29, 2010	NAI	Human Drugs · Bioresearch Monitoring	685618
January 15, 2010	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	641742
November 24, 2009	OAI	Medical Devices & Rad Health · Compliance: Devices	633629

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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