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DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD

Low Risk

FEI: 3017539205 • Dongguan, Guangdong • CHINA

FEI

FEI Number

3017539205

📍

Location

Dongguan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Buidling A Send Floor, No. 4 Yanjiang Road; Fenggang Town, Dongguan, Guangdong, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/3/2020
Latest Refusal
12/3/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
12/3/2020
76EFSUNIT, ORAL IRRIGATION
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD's FDA import refusal history?

DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD (FEI: 3017539205) has 1 FDA import refusal record(s) in our database, spanning from 12/3/2020 to 12/3/2020.

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. DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD's FEI number is 3017539205.

What types of violations has DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD received?

DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD has been cited for 2 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 DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO LTD come from?

All FDA import refusal data for DONGGUAN MNGCHUANG YOUSHANG ELECTRONIC TECH CO 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.