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Henan Maoxiang Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3016943212 • Xinzheng, Henan • CHINA

FEI

FEI Number

3016943212

📍

Location

Xinzheng, Henan

🇨🇳

Country

CHINA
🏢

Address

South Fuyuan Road, Longhuzhen Xinzheng, Xinzheng, Henan, China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/4/2020
Latest Refusal
9/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/4/2020
62HAL99ANTI-MICROBIAL N.E.C.
2280DIRSEXMPT
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

Henan Maoxiang Pharmaceutical Co., Ltd. (FEI: 3016943212) has 1 FDA import refusal record(s) in our database, spanning from 9/4/2020 to 9/4/2020.

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 Maoxiang Pharmaceutical Co., Ltd.'s FEI number is 3016943212.

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

Henan Maoxiang Pharmaceutical Co., Ltd. has been cited for 2 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 Maoxiang Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Henan Maoxiang 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.