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William James

⚠️ Moderate Risk

FEI: 3009032877 • Dubayy • UNITED ARAB EMIRATES

FEI

FEI Number

3009032877

📍

Location

Dubayy

🇦🇪
🏢

Address

Springs 4st 4villa 31, , Dubayy, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
7/28/2011
Latest Refusal
7/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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
7/28/2011
86LPLLENSES, SOFT CONTACT, DAILY WEAR
2480RXPERSONAL
341REGISTERED
Cincinnati District Office (CIN-DO)
7/28/2011
61NCY69GABAPENTIN (ANTI-DEPRESSANT)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is William James's FDA import refusal history?

William James (FEI: 3009032877) has 2 FDA import refusal record(s) in our database, spanning from 7/28/2011 to 7/28/2011.

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. William James's FEI number is 3009032877.

What types of violations has William James received?

William James has been cited for 3 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 William James come from?

All FDA import refusal data for William James 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.