ImportRefusal LogoImportRefusal

SHENZHEN XLXBEST TECH CO., LTD

Low Risk

FEI: 3014830608 • Guangdong • CHINA

FEI

FEI Number

3014830608

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

Building D, Zhunyu Industrial Park No. 11, Linglan Road, Guanlanstreet, Longhua District, Guangdong, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
11/28/2018
Latest Refusal
11/28/2018
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
11/28/2018
79GFEBRUSH, DERMABRASION
118NOT LISTED
3280FRNMFGREG
333LACKS FIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN XLXBEST TECH CO., LTD's FDA import refusal history?

SHENZHEN XLXBEST TECH CO., LTD (FEI: 3014830608) has 1 FDA import refusal record(s) in our database, spanning from 11/28/2018 to 11/28/2018.

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 XLXBEST TECH CO., LTD's FEI number is 3014830608.

What types of violations has SHENZHEN XLXBEST TECH CO., LTD received?

SHENZHEN XLXBEST TECH 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 XLXBEST TECH CO., LTD come from?

All FDA import refusal data for SHENZHEN XLXBEST 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.