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Dafeng Huashu Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3003967531 • Yancheng, Jiangsu • CHINA

FEI

FEI Number

3003967531

📍

Location

Yancheng, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

East of, 1 Zhuyuan Road; Dafeng, Yancheng, 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
11/6/2009
Latest Refusal
11/6/2009
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

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
11/6/2009
56CYY21CEPHALOGLYCIN DIHYDRATE (CEPHALOSPORINS)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dafeng Huashu Pharmaceutical Co., Ltd.'s FDA import refusal history?

Dafeng Huashu Pharmaceutical Co., Ltd. (FEI: 3003967531) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2009 to 11/6/2009.

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. Dafeng Huashu Pharmaceutical Co., Ltd.'s FEI number is 3003967531.

What types of violations has Dafeng Huashu Pharmaceutical Co., Ltd. received?

Dafeng Huashu 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 Dafeng Huashu Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Dafeng Huashu 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.