Ulthera Inc FDA Inspection Record
Ulthera Inc is an FDA-registered facility (FEI 1012187) located in Raleigh, NC, US. RegDataLab tracks 13 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Oct 28, 2025: No Action Indicated (NAI)
- Inspections on record
- 13 (1 OAI, 2 VAI, 10 NAI)
- Last OAI inspection
- Nov 24, 2009
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 4, latest May 20, 2016
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 28, 2025 | No Action Indicated (NAI) | No citations listed |
| Jun 22, 2023 | No Action Indicated (NAI) | No citations listed |
| Sep 18, 2019 | No Action Indicated (NAI) | No citations listed |
| Jul 26, 2018 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Documentation (21 CFR 820.100(b)) |
| Aug 7, 2015 | No Action Indicated (NAI) | No citations listed |
| Jan 26, 2015 | No Action Indicated (NAI) | No citations listed |
| Aug 15, 2014 | No Action Indicated (NAI) | Records of complaint investigation (21 CFR 820.198(e)) |
| Jul 31, 2012 | No Action Indicated (NAI) | No citations listed |
| Jul 21, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 29, 2010 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 20, 2016 | Class II | Z-2607-2016 | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz… Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. |
| Oct 26, 2015 | Class II | Z-0366-2016 | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal… The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is… |
| Oct 26, 2015 | Class II | Z-0367-2016 | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material… and 1 more product The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is… |
| Jul 13, 2004 | Class III | D-229-4 | Nu-Iron¿ V, Polysaccharide-Iron Complex, Each Maroon Film-Coated Tablet contains: Iron… Sub-potent (Calcium Carbonate) |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Merz North America, Inc.
- Location
- Raleigh, NC (US)
- Source
- device