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SHENZHEN HANGSEN BIOTECHNOLOGY C

Low Risk

FEI: 3013530865 • Shenzhen • CHINA

FEI

FEI Number

3013530865

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

5th Fl, Blk B Zhonghaixi, Shenzhen, , China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/3/2021
Latest Refusal
4/3/2021
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

38511×

TPLACKFIRM

This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.

Refusal History

DateProductViolationsDivision
4/3/2021
73CCQNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
3851TPLACKFIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN HANGSEN BIOTECHNOLOGY C's FDA import refusal history?

SHENZHEN HANGSEN BIOTECHNOLOGY C (FEI: 3013530865) has 1 FDA import refusal record(s) in our database, spanning from 4/3/2021 to 4/3/2021.

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 HANGSEN BIOTECHNOLOGY C's FEI number is 3013530865.

What types of violations has SHENZHEN HANGSEN BIOTECHNOLOGY C received?

SHENZHEN HANGSEN BIOTECHNOLOGY C has been cited for 1 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 HANGSEN BIOTECHNOLOGY C come from?

All FDA import refusal data for SHENZHEN HANGSEN BIOTECHNOLOGY C 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.