ImportRefusal LogoImportRefusal

Express International

✅ Low Risk

FEI: 1000327961 • Chandlers Ford • UNITED KINGDOM

FEI

FEI Number

1000327961

📍

Location

Chandlers Ford

🇬🇧
🏢

Address

Marks Brooks Industrial Park School, Unit 13, Chandlers Ford, , United Kingdom

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
3/29/2005
Latest Refusal
3/29/2005
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4841×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/29/2005
86LPLLENSES, SOFT CONTACT, DAILY WEAR
333LACKS FIRM
335LACKS N/C
484DV NAME
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Express International's FDA import refusal history?

Express International (FEI: 1000327961) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 3/29/2005.

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. Express International's FEI number is 1000327961.

What types of violations has Express International received?

Express International 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 Express International come from?

All FDA import refusal data for Express International 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.