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Courier Link Express Pte Ltd

⚠️ Moderate Risk

FEI: 3005129536 • Singapore • SINGAPORE

FEI

FEI Number

3005129536

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

02-18 Cargo Agents Bldg C, , Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

35.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/2/2023
Latest Refusal
11/2/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
55.7×20%
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

1181×

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).

Refusal History

DateProductViolationsDivision
11/2/2023
76DZLSCREW, FIXATION, INTRAOSSEOUS
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Courier Link Express Pte Ltd's FDA import refusal history?

Courier Link Express Pte Ltd (FEI: 3005129536) has 1 FDA import refusal record(s) in our database, spanning from 11/2/2023 to 11/2/2023.

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. Courier Link Express Pte Ltd's FEI number is 3005129536.

What types of violations has Courier Link Express Pte Ltd received?

Courier Link Express Pte Ltd has been cited for 1 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 Courier Link Express Pte Ltd come from?

All FDA import refusal data for Courier Link Express Pte 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.