ImportRefusal LogoImportRefusal

SHENZHEN AILESHENG TECHNOLOGY CO.,LTD

Low Risk

FEI: 3015925085 • Shenzhen • CHINA

FEI

FEI Number

3015925085

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Gno.2 Zhenye Road ,Pingshan District, , 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
11/22/2019
Latest Refusal
11/22/2019
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
11/22/2019
76ELAINSTRUMENT, HAND, CALCULUS REMOVAL
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN AILESHENG TECHNOLOGY CO.,LTD's FDA import refusal history?

SHENZHEN AILESHENG TECHNOLOGY CO.,LTD (FEI: 3015925085) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2019 to 11/22/2019.

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 AILESHENG TECHNOLOGY CO.,LTD's FEI number is 3015925085.

What types of violations has SHENZHEN AILESHENG TECHNOLOGY CO.,LTD received?

SHENZHEN AILESHENG TECHNOLOGY 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 SHENZHEN AILESHENG TECHNOLOGY CO.,LTD come from?

All FDA import refusal data for SHENZHEN AILESHENG 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.