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Tri Nguyen

⚠️ Moderate Risk

FEI: 3006683690 • North York, ON • CANADA

FEI

FEI Number

3006683690

📍

Location

North York, ON

🇨🇦

Country

CANADA
🏢

Address

247 Verobeach Blvd., , North York, ON, Canada

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
4
Unique Violations
3/13/2008
Latest Refusal
3/13/2008
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

751×

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).

Refusal History

DateProductViolationsDivision
3/13/2008
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
333LACKS FIRM
336INCONSPICU
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Tri Nguyen's FDA import refusal history?

Tri Nguyen (FEI: 3006683690) has 1 FDA import refusal record(s) in our database, spanning from 3/13/2008 to 3/13/2008.

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. Tri Nguyen's FEI number is 3006683690.

What types of violations has Tri Nguyen received?

Tri Nguyen 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 Tri Nguyen come from?

All FDA import refusal data for Tri Nguyen 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.