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Henan Shenzhoushen Pharmaceutical Co. Ltd.

⚠️ Moderate Risk

FEI: 3010643007 • Xinye, Henan • CHINA

FEI

FEI Number

3010643007

📍

Location

Xinye, Henan

🇨🇳

Country

CHINA
🏢

Address

Xinye Economic & Technological Ind. Park, , Xinye, Henan, 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
3/3/2014
Latest Refusal
3/3/2014
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
3/3/2014
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Henan Shenzhoushen Pharmaceutical Co. Ltd.'s FDA import refusal history?

Henan Shenzhoushen Pharmaceutical Co. Ltd. (FEI: 3010643007) has 1 FDA import refusal record(s) in our database, spanning from 3/3/2014 to 3/3/2014.

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. Henan Shenzhoushen Pharmaceutical Co. Ltd.'s FEI number is 3010643007.

What types of violations has Henan Shenzhoushen Pharmaceutical Co. Ltd. received?

Henan Shenzhoushen 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 Henan Shenzhoushen Pharmaceutical Co. Ltd. come from?

All FDA import refusal data for Henan Shenzhoushen 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.