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Amino Life(Wuxi) Biotech Co.,Ltd

⚠️ Moderate Risk

FEI: 3010287417 • Wuxi, Jiangsu • CHINA

FEI

FEI Number

3010287417

📍

Location

Wuxi, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

NO 518 Xinggangnanlu, Xishan, Wuxi, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/11/2019
Latest Refusal
7/11/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

Refusal History

DateProductViolationsDivision
7/11/2019
54CBR12L-LEUCINE (PROTEIN)
238UNSAFE ADD
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Amino Life(Wuxi) Biotech Co.,Ltd's FDA import refusal history?

Amino Life(Wuxi) Biotech Co.,Ltd (FEI: 3010287417) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2019 to 7/11/2019.

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. Amino Life(Wuxi) Biotech Co.,Ltd's FEI number is 3010287417.

What types of violations has Amino Life(Wuxi) Biotech Co.,Ltd received?

Amino Life(Wuxi) Biotech 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 Amino Life(Wuxi) Biotech Co.,Ltd come from?

All FDA import refusal data for Amino Life(Wuxi) Biotech 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.