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Yangzhou Aurisco Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3021695089 • Yangzhou, Jiangsu • CHINA

FEI

FEI Number

3021695089

📍

Location

Yangzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

High-Tech, No. 28 Jianan Road; Industrial Development Zone, Yangzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

46.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/20/2025
Latest Refusal
6/20/2025
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
88.6×20%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
6/20/2025
61PIY72SEMAGLUTIDE (ANTI-DIABETIC)
2280DIRSEXMPT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Yangzhou Aurisco Pharmaceutical Co., Ltd.'s FDA import refusal history?

Yangzhou Aurisco Pharmaceutical Co., Ltd. (FEI: 3021695089) has 1 FDA import refusal record(s) in our database, spanning from 6/20/2025 to 6/20/2025.

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. Yangzhou Aurisco Pharmaceutical Co., Ltd.'s FEI number is 3021695089.

What types of violations has Yangzhou Aurisco Pharmaceutical Co., Ltd. received?

Yangzhou Aurisco Pharmaceutical 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 Yangzhou Aurisco Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Yangzhou Aurisco Pharmaceutical 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.