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Nu Skin Canada Inc

✅ Low Risk

FEI: 3003163284 • Richmond, BC • CANADA

FEI

FEI Number

3003163284

📍

Location

Richmond, BC

🇨🇦

Country

CANADA
🏢

Address

6551 Westminster Hwy, , Richmond, BC, Canada

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
4
Unique Violations
12/17/2013
Latest Refusal
12/17/2013
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

2371×

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).

3411×

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).

37411×

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.

Refusal History

DateProductViolationsDivision
12/17/2013
89EGJDEVICE, IONTOPHORESIS, OTHER USES
118NOT LISTED
237NO PMA
341REGISTERED
3741FRNMFGREG
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Nu Skin Canada Inc's FDA import refusal history?

Nu Skin Canada Inc (FEI: 3003163284) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2013 to 12/17/2013.

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 Canada Inc's FEI number is 3003163284.

What types of violations has Nu Skin Canada Inc received?

Nu Skin Canada Inc has been cited for 4 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 Canada Inc come from?

All FDA import refusal data for Nu Skin Canada 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.