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Jetcrown Industrial (Marco Commercial Offshore) Limited

✅ Low Risk

FEI: 3006072095 • Macau • CHINA

FEI

FEI Number

3006072095

📍

Location

Macau

🇨🇳

Country

CHINA
🏢

Address

17b, Edificio Comercial Rodrigues, , Macau, , China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/14/2008
Latest Refusal
10/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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).

Refusal History

DateProductViolationsDivision
10/14/2008
79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
341REGISTERED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Jetcrown Industrial (Marco Commercial Offshore) Limited's FDA import refusal history?

Jetcrown Industrial (Marco Commercial Offshore) Limited (FEI: 3006072095) has 1 FDA import refusal record(s) in our database, spanning from 10/14/2008 to 10/14/2008.

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. Jetcrown Industrial (Marco Commercial Offshore) Limited's FEI number is 3006072095.

What types of violations has Jetcrown Industrial (Marco Commercial Offshore) Limited received?

Jetcrown Industrial (Marco Commercial Offshore) Limited 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 Jetcrown Industrial (Marco Commercial Offshore) Limited come from?

All FDA import refusal data for Jetcrown Industrial (Marco Commercial Offshore) Limited 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.