SHENZHEN DONGJILIAN ELECTRONICS CO., LTD

⚠️ High Risk

FEI: 3010894709 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3010894709

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA

🏢

Address

Building 3 F/3, Busha Road,Nanwan Street, Longgang, Shenzhen, Guangdong, China

High Risk

FDA Import Risk Assessment

53.7

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

114

Total Refusals

Unique Violations

2/28/2020

Latest Refusal

12/30/2019

Earliest Refusal

Score Breakdown

Violation Severity

52.0×40%

Refusal Volume

76.3×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

3280108×

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.

22336×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

11835×

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

Date	Product	Violations	Division
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/28/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED	Division of Northern Border Imports (DNBI)
2/27/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/24/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/24/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/19/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/18/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	223FALSE	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	223FALSE	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/10/2020	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 223FALSE 3280FRNMFGREG	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN DONGJILIAN ELECTRONICS CO., LTD's FDA import refusal history?

SHENZHEN DONGJILIAN ELECTRONICS CO., LTD (FEI: 3010894709) has 114 FDA import refusal record(s) in our database, spanning from 12/30/2019 to 2/28/2020.

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. SHENZHEN DONGJILIAN ELECTRONICS CO., LTD's FEI number is 3010894709.

What types of violations has SHENZHEN DONGJILIAN ELECTRONICS CO., LTD received?

SHENZHEN DONGJILIAN ELECTRONICS CO., LTD 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 SHENZHEN DONGJILIAN ELECTRONICS CO., LTD come from?

All FDA import refusal data for SHENZHEN DONGJILIAN ELECTRONICS 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.