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Henan Lihua Pharmaceutical Co Ltd

⚠️ Moderate Risk

FEI: 3010080114 • Zhengzhou, Henan • CHINA

FEI

FEI Number

3010080114

📍

Location

Zhengzhou, Henan

🇨🇳

Country

CHINA
🏢

Address

Dongfang Guoji Building Room 606, ZHOUZHENG ZHOU, Zhengzhou, Henan, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/3/2013
Latest Refusal
5/3/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
5/3/2013
64LCY38HYDROCORTISONE ACETATE (GLUCOCORTICOID)
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

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

Henan Lihua Pharmaceutical Co Ltd (FEI: 3010080114) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2013 to 5/3/2013.

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 Lihua Pharmaceutical Co Ltd's FEI number is 3010080114.

What types of violations has Henan Lihua Pharmaceutical Co Ltd received?

Henan Lihua 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 Lihua Pharmaceutical Co Ltd come from?

All FDA import refusal data for Henan Lihua 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.