ImportRefusal LogoImportRefusal

Linkgen Biotech (Shanghai) Co.,Ltd.

⚠️ Moderate Risk

FEI: 3015169734 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3015169734

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Room 3313 3th Floor, No. 17 Jinzhong Road; Changning District, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/3/2020
Latest Refusal
8/3/2020
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2231×

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.

Refusal History

DateProductViolationsDivision
8/3/2020
80KXGAPPLICATOR, ABSORBENT TIPPED, STERILE
223FALSE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Linkgen Biotech (Shanghai) Co.,Ltd.'s FDA import refusal history?

Linkgen Biotech (Shanghai) Co.,Ltd. (FEI: 3015169734) has 1 FDA import refusal record(s) in our database, spanning from 8/3/2020 to 8/3/2020.

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. Linkgen Biotech (Shanghai) Co.,Ltd.'s FEI number is 3015169734.

What types of violations has Linkgen Biotech (Shanghai) Co.,Ltd. received?

Linkgen Biotech (Shanghai) Co.,Ltd. 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 Linkgen Biotech (Shanghai) Co.,Ltd. come from?

All FDA import refusal data for Linkgen Biotech (Shanghai) 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.