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Ultravision International Ltd.

⚠️ Moderate Risk

FEI: 3002807254 • Leighton Buzzard • UNITED KINGDOM

FEI

FEI Number

3002807254

📍

Location

Leighton Buzzard

🇬🇧
🏢

Address

Commerce Way, LEIGHTON BUZZARD, Leighton Buzzard, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/26/2005
Latest Refusal
5/26/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

29401×

COSM MISB

The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

Refusal History

DateProductViolationsDivision
5/26/2005
86LPLLENSES, SOFT CONTACT, DAILY WEAR
2940COSM MISB
310POISONOUS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ultravision International Ltd.'s FDA import refusal history?

Ultravision International Ltd. (FEI: 3002807254) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2005 to 5/26/2005.

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. Ultravision International Ltd.'s FEI number is 3002807254.

What types of violations has Ultravision International Ltd. received?

Ultravision International Ltd. has been cited for 2 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 Ultravision International Ltd. come from?

All FDA import refusal data for Ultravision International Ltd. 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.