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DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY CO., LTD.

⚠️ Moderate Risk

FEI: 3005690137 • Dongguan, Guangdong • CHINA

FEI

FEI Number

3005690137

📍

Location

Dongguan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Room 103, Building 1, No.6, Yinfeng 1st Road, Xiegang Town; Xiagang Town, Dongguan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
1/5/2007
Latest Refusal
9/19/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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).

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).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
1/5/2007
79LEJBOOTH, SUN TAN
118NOT LISTED
47NON STD
Chicago District Office (CHI-DO)
9/19/2006
95U19SUNLAMP PRODUCT (PRE-STANDARD) FOR NON-MEDICAL USE
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY CO., LTD.'s FDA import refusal history?

DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY CO., LTD. (FEI: 3005690137) has 2 FDA import refusal record(s) in our database, spanning from 9/19/2006 to 1/5/2007.

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. DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY CO., LTD.'s FEI number is 3005690137.

What types of violations has DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY CO., LTD. received?

DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY 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 DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY CO., LTD. come from?

All FDA import refusal data for DONG GUAN FUMEIKANG ELECTRICAL TECHNOLOGY 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.