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Taizhou Highsun Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3006210791 • Taizhou, Zhejiang • CHINA

FEI

FEI Number

3006210791

📍

Location

Taizhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Zhejiang Province Chemical, Pharmaceutical Base of Linhai Zone, Taizhou, Zhejiang, 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
9/9/2011
Latest Refusal
9/9/2011
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
9/9/2011
62GCE99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Taizhou Highsun Pharmaceutical Co., Ltd.'s FDA import refusal history?

Taizhou Highsun Pharmaceutical Co., Ltd. (FEI: 3006210791) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.

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. Taizhou Highsun Pharmaceutical Co., Ltd.'s FEI number is 3006210791.

What types of violations has Taizhou Highsun Pharmaceutical Co., Ltd. received?

Taizhou Highsun 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 Taizhou Highsun Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Taizhou Highsun 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.