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Drx Meditech

⚠️ Moderate Risk

FEI: 3005555810 • Singapore • SINGAPORE

FEI

FEI Number

3005555810

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

213 Henderson Rd 0108, , Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

28.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
2/1/2007
Latest Refusal
5/3/2006
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
2/1/2007
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
474COSMETLBLG
New Orleans District Office (NOL-DO)
2/1/2007
53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
118NOT LISTED
New Orleans District Office (NOL-DO)
5/3/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Drx Meditech's FDA import refusal history?

Drx Meditech (FEI: 3005555810) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2006 to 2/1/2007.

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. Drx Meditech's FEI number is 3005555810.

What types of violations has Drx Meditech received?

Drx Meditech 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 Drx Meditech come from?

All FDA import refusal data for Drx Meditech 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.