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Wong Dr Lawrence Mk

⚠️ Moderate Risk

FEI: 3004500858 • Singapore • SINGAPORE

FEI

FEI Number

3004500858

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

820 Duneem Rd, , Singapore, , Singapore

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

2
Total Refusals
3
Unique Violations
5/26/2004
Latest Refusal
5/26/2004
Earliest Refusal

Score Breakdown

Violation Severity
62.5×40%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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.

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
5/26/2004
54FBP12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
16DIRECTIONS
333LACKS FIRM
New Orleans District Office (NOL-DO)
5/26/2004
55QY30WHITE OINTMENT (PHARMACEUTIC NECESSITY - OLEAGINOUS)
16DIRECTIONS
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wong Dr Lawrence Mk's FDA import refusal history?

Wong Dr Lawrence Mk (FEI: 3004500858) has 2 FDA import refusal record(s) in our database, spanning from 5/26/2004 to 5/26/2004.

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. Wong Dr Lawrence Mk's FEI number is 3004500858.

What types of violations has Wong Dr Lawrence Mk received?

Wong Dr Lawrence Mk 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 Wong Dr Lawrence Mk come from?

All FDA import refusal data for Wong Dr Lawrence Mk 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.