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Universal Handicraft Inc

⚠️ Moderate Risk

FEI: 3004756694 • Miami Beach, FL • UNITED STATES

FEI

FEI Number

3004756694

📍

Location

Miami Beach, FL

🇺🇸
🏢

Address

1400 Alton Rd Ste 201, , Miami Beach, FL, United States

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/9/2017
Latest Refusal
4/24/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
3.8×10%
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
2/9/2017
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
2/9/2017
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)
4/24/2009
62FBU99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Universal Handicraft Inc's FDA import refusal history?

Universal Handicraft Inc (FEI: 3004756694) has 3 FDA import refusal record(s) in our database, spanning from 4/24/2009 to 2/9/2017.

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. Universal Handicraft Inc's FEI number is 3004756694.

What types of violations has Universal Handicraft Inc received?

Universal Handicraft Inc 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 Universal Handicraft Inc come from?

All FDA import refusal data for Universal Handicraft 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.