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Zhejiang Xianju Xianle Pharmaceutical Co., Ltd.

⚠️ High Risk

FEI: 3008465731 • Taizhou, Zhejiang • CHINA

FEI

FEI Number

3008465731

📍

Location

Taizhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

5 South Chuancheng Rd., , Taizhou, Zhejiang, China

High Risk

FDA Import Risk Assessment

50.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
7/31/2023
Latest Refusal
7/31/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
50.4×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
7/31/2023
64LIS50PREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Zhejiang Xianju Xianle Pharmaceutical Co., Ltd.'s FDA import refusal history?

Zhejiang Xianju Xianle Pharmaceutical Co., Ltd. (FEI: 3008465731) has 1 FDA import refusal record(s) in our database, spanning from 7/31/2023 to 7/31/2023.

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. Zhejiang Xianju Xianle Pharmaceutical Co., Ltd.'s FEI number is 3008465731.

What types of violations has Zhejiang Xianju Xianle Pharmaceutical Co., Ltd. received?

Zhejiang Xianju Xianle 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 Zhejiang Xianju Xianle Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Zhejiang Xianju Xianle 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.