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Optigenex

⚠️ Moderate Risk

FEI: 3010275482 • Hoboken, NJ • UNITED STATES

FEI

FEI Number

3010275482

📍

Location

Hoboken, NJ

🇺🇸
🏢

Address

333 River St, , Hoboken, NJ, United States

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/16/2013
Latest Refusal
9/16/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
9/16/2013
53CC04EYE LOTION (EYE MAKEUP PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
9/16/2013
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
9/16/2013
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Optigenex's FDA import refusal history?

Optigenex (FEI: 3010275482) has 3 FDA import refusal record(s) in our database, spanning from 9/16/2013 to 9/16/2013.

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. Optigenex's FEI number is 3010275482.

What types of violations has Optigenex received?

Optigenex has been cited for 1 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 Optigenex come from?

All FDA import refusal data for Optigenex 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.