Nu Skin International, Inc.
⚠️ Moderate Risk
FEI: 3004333939 • Provo, UT • UNITED STATES
FEI Number
3004333939
Location
Provo, UT
Country
UNITED STATESAddress
275 E 1325 S, , Provo, UT, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2014 | 84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE | Seattle District Office (SEA-DO) | |
| 4/10/2014 | 84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE | Florida District Office (FLA-DO) | |
| 12/17/2013 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Seattle District Office (SEA-DO) | |
| 12/17/2013 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Seattle District Office (SEA-DO) | |
| 9/15/2010 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Florida District Office (FLA-DO) | |
| 9/15/2010 | 66VNJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/15/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Nu Skin International, Inc.'s FDA import refusal history?
Nu Skin International, Inc. (FEI: 3004333939) has 7 FDA import refusal record(s) in our database, spanning from 12/15/2008 to 7/22/2014.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Nu Skin International, Inc.'s FEI number is 3004333939.
What types of violations has Nu Skin International, Inc. received?
Nu Skin International, Inc. has been cited for 8 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Nu Skin International, Inc. come from?
All FDA import refusal data for Nu Skin International, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.