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SHENZHEN DONGJILIAN ELECTRONICS

✅ Low Risk

FEI: 3015812349 • Shenzhen • CHINA

FEI

FEI Number

3015812349

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

3/F,Building 3,Baimenqi, , Shenzhen, , 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
12/30/2019
Latest Refusal
12/30/2019
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
12/30/2019
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SHENZHEN DONGJILIAN ELECTRONICS's FDA import refusal history?

SHENZHEN DONGJILIAN ELECTRONICS (FEI: 3015812349) has 1 FDA import refusal record(s) in our database, spanning from 12/30/2019 to 12/30/2019.

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. SHENZHEN DONGJILIAN ELECTRONICS's FEI number is 3015812349.

What types of violations has SHENZHEN DONGJILIAN ELECTRONICS received?

SHENZHEN DONGJILIAN ELECTRONICS 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 SHENZHEN DONGJILIAN ELECTRONICS come from?

All FDA import refusal data for SHENZHEN DONGJILIAN ELECTRONICS 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.